LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib

NCT00680901 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: EGF1106562007-005725-29CLAP016C2301
• Study Type: interventional
• Target: 545
• Locations: 23 countries
• Sites: 183

Brief Summary

This was an international multi-center trial that enrolled patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors had amplification of the ErbB2 (HER2) gene. The trial investigated whether lapatinib, when added to the chemotherapy regimen, capecitabine plus oxaliplatin (CapeOx), extended the time to progression and overall survival. Tumor ErbB2 (HER2) status had to be known before trial entry. CapeOx was administered to all patients, and patients were randomly assigned to receive either lapatinib or placebo.

Conditions

Neoplasms, Gastrointestinal Tract

Keywords

unresectable; HER2; ErbB2; TYKERB; capecitabine; CapeOx; gastric/esophageal cancer; GE junction; metastatic; lapatinib; oxaliplatin

Outcome Measures

Primary Outcomes (2)

• Overall Survival at the Time of Primary Analysis

  Overall Survival was defined as the time from randomization to death from any cause. Participants who had not died were censored at their follow-up visit, either because follow-up had ended or was still ongoing.

  From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years)

• Overall Survival in All Randomized Participants at the Time of Primary Analysis

  Overall Survival was defined as the time from randomization to death from any cause. Participants who had not died were censored at their follow-up visit, either because follow-up had ended or was still ongoing.

  From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years)

Secondary Outcomes (15)

• Overall Survival at the Time of Final Analysis

  From date of randomization till death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

• Progression Free Survival (PFS)

  From date of randomization till the earliest date of disease progression or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

• Percentage of Participants With a Confirmed Complete Response (CR) or a Partial Response (PR)

  From date of randomization till the date of the first documented response of CR or PR, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

• Percentage of Participants With Clinical Benefit (CB)

  From date of randomization till date of disease progression (PD) or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

• Time to Response (TTR)

  From date of randomization till the first documented evidence of confirmed CR or PR, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

Study Arms (2)

CapeOx plus Lapatinib

EXPERIMENTAL

CapeOx plus Lapatinib

Drug: Lapatinib; Drug: Capecitabine; Drug: Oxaliplatin

CapeOx plus Placebo

PLACEBO COMPARATOR

CapeOx plus Placebo

Drug: Placebo; Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Lapatinib DRUG

5 pills at 250mg each once daily

Also known as: Tykerb

CapeOx plus Lapatinib

Placebo DRUG

5 pills once daily

CapeOx plus Placebo

Capecitabine DRUG

1700mg/m2/day in two daily doses

CapeOx plus Lapatinib; CapeOx plus Placebo

Oxaliplatin DRUG

130mg/m2 on day 1

CapeOx plus Lapatinib; CapeOx plus Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the esophagus or gastro-esophageal junction.
• Gastric cancer that is unresectable due to locally advanced (defined as stage IV: T4N1-3 or TanyN3), metastatic, or locally recurrent disease; Esophageal cancer that is unresectable due to locally advanced (T3N1 or T4Nany), metastatic or locally recurrent disease.
• Measurable or non-measurable, but radiologically evaluable disease, according to RECIST.
• HER2 amplification by FISH assessed by the local or designated central laboratory; Subjects with unknown HER2 status were not eligible.
• Adequate organ function, as defined in the study protocol, assessed within 14 days prior randomization.
• Cardiac ejection fraction within institutional range of normal as measured by echocardiogram (ECHO).
• Prior/Concurrent Therapy:
• At least 3 weeks following major surgery, such as gastrectomy, and were recovered from any related toxicity More than 5 years since prior chemotherapy for malignancy other than GC. At least 4 weeks since prior radiotherapy
• More than 5 years since prior biologic or hormonal therapy or immunotherapy for malignancy other than gastric carcinoma.

You may not qualify if:

• Pregnant or lactating females at any time during the study.
• Known history of active CNS disease.
• Uncontrolled ascites.
• Concurrent anti-cancer therapy (chemotherapy, radiation therapy other than for pain relief, immunotherapy, biologic therapy, hormonal therapy or surgery) while taking investigational treatment.
• Gastric carcinoid, epidermoid, sarcomas, or squamous cell carcinoma.
• Prior palliative chemotherapy for the treatment of gastric cancer.
• Prior treatment with oxaliplatin-based neoadjuvant or adjuvant chemotherapy completed \<12 months.
• Malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease (such as Crohn's disease or ulcerative colitis).
• Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
• Uncontrolled infection.
• History of other malignancy. However, subjects who were disease-free for 5 years, or subjects with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, were eligible.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (183)

Novartis Investigative Site

Alhambra, California, 91801, United States

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Novartis Investigative Site

Fullerton, California, 92835, United States

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La Verne, California, 91750, United States

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Northridge, California, 91328, United States

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Oxnard, California, 93030, United States

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Redondo Beach, California, 90277, United States

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Santa Maria, California, 93454, United States

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Santa Monica, California, 90404, United States

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Terre Haute, Indiana, 47802, United States

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Henderson, Nevada, 89052, United States

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Ciudad Aut6noma de Buenos Aires, Buenos Aires, C1050AAK, Argentina

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Quilmes, Buenos Aires, 1878, Argentina

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Neuquén, Neuquén Province, Q8300HDH, Argentina

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Cipolletti, Río Negro Province, R8324EMB, Argentina

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Rosario, Santa Fe Province, S2000KZE, Argentina

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Buenos Aires, 1264, Argentina

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La Rioja, F5300COE, Argentina

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San Miguel de Tucumán, 4000, Argentina

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Santa Fe, 3000, Argentina

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Belo Horizonte, Minas Gerais, 30110-090, Brazil

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Belo Horizonte, Minas Gerais, 30150-281, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

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Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

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Florianópolis, Santa Catarina, 88034-000, Brazil

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Barretos, São Paulo, 14784-400, Brazil

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Jaú, São Paulo, 17210-120, Brazil

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Santo André, São Paulo, 09060-650, Brazil

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São Paulo, São Paulo, 01221-020, Brazil

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São Paulo, São Paulo, 01246-000, Brazil

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São Paulo, São Paulo, 01308-500, Brazil

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Rio de Janeiro, 20230-130, Brazil

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Edmonton, Alberta, T6G 1Z2, Canada

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Vancouver, British Columbia, V5Z 4E6, Canada

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Saint John, New Brunswick, E2L 4L2, Canada

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London, Ontario, N6A 4L6, Canada

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Toronto, Ontario, M4C 3E7, Canada

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Toronto, Ontario, M5B 1W8, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H2W 1S6, Canada

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Montreal, Quebec, H3G 1A4, Canada

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Temuco, Región de La Araucania, 481-0469, Chile

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Viña del Mar, Región de Valparaíso, 254-0364, Chile

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Santiago, Región Metro de Santiago, 7500921, Chile

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Santiago, 7510032, Chile

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Hefei, Anhui, 230022, China

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Guangzhou, Guangdong, 510515, China

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Harbin, Heilongjiang, 150040, China

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Nanjing, Jiangsu, 210002, China

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Changchun, Jilin, 130012, China

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Chengdu, Sichuan, 610041, China

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Beijing, 100021, China

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Beijing, 100071, China

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Beijing, 100853, China

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Fuzhou, 350025, China

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Hangzhou, 310016, China

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Qingdao, 266061, China

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Shanghai, 200032, China

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Shanghai, 200080, China

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Tianjin, 300060, China

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Tallinn, 13419, Estonia

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Tartu, 51014, Estonia

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Pokfulam, Hong Kong

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Tuenmen, Hong Kong

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Győr, H-9024, Hungary

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Kaposvár, 7400, Hungary

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Kecskemét, 6000, Hungary

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Miskolc, 3526, Hungary

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Pécs, 7624, Hungary

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Szeged, 6720, Hungary

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Szolnok, 5004, Hungary

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Coimbatore, 641037, India

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Kochi, 682041, India

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Kochi, India

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Kolkata, 700 053, India

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Kolkata, 700026, India

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Nagpur, 440010, India

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New Delhi, India

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Pārel, 400012, India

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Pune, 411001, India

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Trivandrum, 695011, India

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Beersheba, 84101, Israel

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Haifa, 31096, Israel

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Jerusalem, 91031, Israel

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Petah Tikva, 49100, Israel

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Ramat Gan, 52621, Israel

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Rehovot, 76100, Israel

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Tel Aviv, 64239, Israel

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Zrifin, 70300, Israel

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L’Aquila, Abruzzo, 67100, Italy

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Bari, Apulia, 70124, Italy

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Rionero in Vulture (PZ), Basilicate, 85028, Italy

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Cesena, Emilia-Romagna, 47023, Italy

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Meldola (FC), Emilia-Romagna, 47014, Italy

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Modena, Emilia-Romagna, 41100, Italy

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Parma, Emilia-Romagna, 43100, Italy

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Piacenza, Emilia-Romagna, 29100, Italy

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Rimini, Emilia-Romagna, 47900, Italy

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Udine, Friuli Venezia Giulia, 33100, Italy

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Rome, Lazio, 00152, Italy

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Rome, Lazio, 00161, Italy

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Rome, Lazio, 00168, Italy

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Genoa, Liguria, 16132, Italy

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Bergamo, Lombardy, 24128, Italy

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Treviglio (BG), Lombardy, 24047, Italy

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Pesasro, The Marches, 61122, Italy

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Florence, Tuscany, 50139, Italy

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Macerata, Italy

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Acapulco de Juárez, Guerrero, 39670, Mexico

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Mexico City, CP 14080, Mexico

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Oaxaca City, 68000, Mexico

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Amsterdam, 1105 AZ, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Nijmegen, 6525 GA, Netherlands

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Callao, Callao 2, Peru

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Lima, Lima 11, Peru

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Lima, Lima 34, Peru

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Gdansk, 80-219, Poland

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Krakow, 31-501, Poland

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Olsztyn, 10-226, Poland

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Olsztyn, 10-513, Poland

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Poznan, 61-866, Poland

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Płock, 09-400, Poland

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Rybnik, 44-200, Poland

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Szczecin, 70-111, Poland

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Słupsk, 76-200, Poland

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Torun, 87-100, Poland

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Warsaw, 02-507, Poland

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Warsaw, 02-781, Poland

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San Juan, 00910, Puerto Rico

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Chelyabinsk, 454087, Russia

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Kirov, 610021, Russia

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Kursk, 305035, Russia

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Moscow, 115478, Russia

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Omsk, 644013, Russia

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Ryazan, 390011, Russia

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Saint Petersburg, 197758, Russia

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Saint Petersburg, 198255, Russia

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Saratov, 410004, Russia

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Sochi, 354057, Russia

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Stavropol, 355047, Russia

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Ufa, 450054, Russia

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Busan, 602-030, South Korea

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Daegu, 700-712, South Korea

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Hwasun, 519-809, South Korea

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Seodaemun-gu, Seoul, 120-752, South Korea

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Seoul, 110-744, South Korea

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Seoul, 135-710, South Korea

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Seoul, 135-720, South Korea

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Seoul, 136-705, South Korea

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Suwon, 442-723, South Korea

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Suwon, Kyonggi-do, 443-721, South Korea

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Tainan, 704, Taiwan

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Taipei, 104, Taiwan

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Taipei, 112, Taiwan

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Taoyuan, 333, Taiwan

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Hatyai, Songkhla, 90110, Thailand

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Ankara, 06500, Turkey (Türkiye)

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Gaziantep, 27310, Turkey (Türkiye)

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Trabzon, 61187, Turkey (Türkiye)

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Cherkasy, 18009, Ukraine

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Chernivtsi, 58013, Ukraine

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Dnipro, 49102, Ukraine

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Dnipropetrovsk, 49100, Ukraine

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Donetsk, 83092, Ukraine

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Ivano-Frankivsk, 76018, Ukraine

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Kharkiv, 61070, Ukraine

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Kryvyi Rih, 50048, Ukraine

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Kyiv, 03022, Ukraine

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Kyiv, 03115, Ukraine

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Kyiv, 04107, Ukraine

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Lutsk, 43018, Ukraine

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Lviv, 79031, Ukraine

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Odesa, 65055, Ukraine

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Plyuty, 08720, Ukraine

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Simferopil, 95023, Ukraine

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Simferopol, 95023, Ukraine

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Sumy, 40005, Ukraine

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Ternopil, 46023, Ukraine

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Uzhhorod, 88000, Ukraine

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Vinnitsia, 21029, Ukraine

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Zaporizhzhia, 69040, Ukraine

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Related Publications (2)

• Chu MP, Hecht JR, Slamon D, Wainberg ZA, Bang YJ, Hoff PM, Sobrero A, Qin S, Afenjar K, Houe V, King K, Koski S, Mulder K, Hiller JP, Scarfe A, Spratlin J, Huang YJ, Khan-Wasti S, Chua N, Sawyer MB. Association of Proton Pump Inhibitors and Capecitabine Efficacy in Advanced Gastroesophageal Cancer: Secondary Analysis of the TRIO-013/LOGiC Randomized Clinical Trial. JAMA Oncol. 2017 Jun 1;3(6):767-773. doi: 10.1001/jamaoncol.2016.3358.

  PMID: 27737436 DERIVED

• Hecht JR, Bang YJ, Qin SK, Chung HC, Xu JM, Park JO, Jeziorski K, Shparyk Y, Hoff PM, Sobrero A, Salman P, Li J, Protsenko SA, Wainberg ZA, Buyse M, Afenjar K, Houe V, Garcia A, Kaneko T, Huang Y, Khan-Wasti S, Santillana S, Press MF, Slamon D. Lapatinib in Combination With Capecitabine Plus Oxaliplatin in Human Epidermal Growth Factor Receptor 2-Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Adenocarcinoma: TRIO-013/LOGiC--A Randomized Phase III Trial. J Clin Oncol. 2016 Feb 10;34(5):443-51. doi: 10.1200/JCO.2015.62.6598. Epub 2015 Nov 30.

  PMID: 26628478 DERIVED

MeSH Terms

Conditions

Neoplasms; Esophageal Neoplasms; Neoplasm Metastasis

Interventions

Lapatinib; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2008
• First Posted: May 20, 2008
• Study Start: June 4, 2008
• Primary Completion: September 24, 2012
• Study Completion: October 3, 2024
• Last Updated: August 7, 2025
• Results First Posted: October 29, 2013

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

IL (8); IT (19); NL (3); PE (3); KR (10); ME (3); BR (12); IN (10); CA (9); HK (2); CL (4); ES (2); PR (1); TW (4); TU (3); UA (22); RU (12); US (10); AR (9); TH (3); HU (7); PL (12); CN (15)