ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.

NCT01774721 | Completed Phase 3 Results DMC

• 2 other identifiers: A7471050DP312804
• Study Type: interventional
• Target: 452
• Locations: 7 countries
• Sites: 52

Brief Summary

This is a multinational, multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of treatment with dacomitinib (PF-00299804) to treatment with gefitinib in patients with locally advanced or metastatic non-small cell lung cancer, with epidermal growth factor receptor EGFR-activating mutation (s). Analyses of primary objective (Progression Free Survival) will be done as defined in the protocol.

Conditions

Non-small Cell Lung Cancer With EGFR-Activating Mutations

Keywords

first-line; locally advanced or metastatic; non-small cell lung cancer; epidermal growth factor receptor; EGFR; ARCHER; mutation; dacomitinib; PF-00299804

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) Based on Independent Radiologic Central (IRC) Review

  PFS: time from randomization to date of progression of disease (PD) as determined by IRC review as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or death due to any cause, whichever occurred first. PD: \>=20% increase in sum of diameters of target lesions (TLs), referring smallest sum on study, sum must be an absolute increase of \>=5 mm, appearance of \>=1 new lesions; unequivocal progression of existing non TLs. Overall tumor burden increased sufficiently to merit discontinuation of therapy. In presence of stable disease (did not achieve partial response, complete response or PD) or partial response (\>=30% decrease under baseline of sum of diameters of all target measurable lesions, short diameter used in the sum for target nodes, longest diameter used in sum for all other target lesions) in target disease; for new lesions: appearance of any new unequivocal malignant lesion indicated PD.

  Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression or death due to any cause, whichever occurred first (up to 48 months)

Secondary Outcomes (24)

• Overall Survival (OS)

  From randomization until death or last date known as alive, up to 45 months

• OS at 30 Months (OS30m)

  Up to 30 months from date of randomization

• Progression Free Survival (PFS) Based on Investigator Assessment

  Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression or death due to any cause, whichever occurred first (up to 48 months)

• Number of Participants With Best Overall Response (BOR) Based on IRC Review

  Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)

• Number of Participants With Best Overall Response (BOR) Based on Investigator Assessment

  Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)

Study Arms (2)

Dacomitinib (PF-00299804)

EXPERIMENTAL

Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing.

Drug: Dacomitinib (PF-00299804)

gefitinib

ACTIVE COMPARATOR

Gefitinib is provided as 250 mg tablets, continuous oral daily dosing.

Drug: Gefitinib

Interventions

Dacomitinib (PF-00299804) DRUG

Dacomitinib (PF-00299804) 45 mg tablets, continuous oral daily dosing.

Also known as: Dacomitinib

Dacomitinib (PF-00299804)

Gefitinib DRUG

Gefitinib 250 mg tablets, continuous oral daily dosing.

Also known as: Iressa

gefitinib

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of histo or cytopathology confirmed, advanced NSCLC (with known histology) with the presence of EGFR-activating mutation (exon 19 deletion or the L858R mutation in exon 21).
• It is acceptable for subjects with the presence of the exon 20 T790M mutation together with either EGFR-activating mutation (exon 19 deletion or the L858R mutation in exon 21) to be included in this study
• No prior treatment with systemic therapy for locally advanced or metastatic NSCLC. Minimum of 12 months disease free interval between completion of neoadjuvant/adjuvant systemic therapy and recurrence of NSCLC
• Adequate tissue sample must be available for central analyses.
• Adequate renal, hematologic, liver function.
• ECOG PS of 0-1.
• Radiologically measurable disease.

You may not qualify if:

• Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer.
• Any other mutation other than exon 19 deletion or L858R in exon 21, with or without the presence of the exon 20 T790M mutation.
• Any history of brain metastases or leptomeningeal metastases.
• Any previous anti-cancer systemic treatment of early, locally advanced, or metastatic NSCLC.
• Any surgery(not including minor procedures such as lymph node biopsy), palliative radiotherapy or pleurodesis within 2 weeks of baseline assessments
• Any clinically significant gastrointestinal abnormalities that may impair intake, transit or absorption of the study drug.
• Current enrollment in another therapeutic clinical study.
• History of, or currently suspected, diffuse non-infectious pneumonitis or interstitial lung disease
• Uncontrolled medical disorders.
• Prior malignancy and concurrent malignancy except for non melanoma skin cancer or in-situ cervical cancer with no evidence of active disease.
• Use of narrow therapeutic index drugs that are CYP2D6 substrates from screening to randomization.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (52)

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Beijing, China

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Changchun, China

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Changsha, China

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Chengdu, China

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Chongqing, China

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Fuzhou, China

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Guangzhou, China

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Hangzhou, China

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Hefei, China

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Nanning, China

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Shanghai, China

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Shenyang, China

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Tianjin, China

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Wuhan, China

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Wuxi, China

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Hong Kong, Hong Kong

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Shatin, Hong Kong

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Catania, Italy

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Lecco, Italy

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Livorno, Italy

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Meldola, Italy

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Milan, Italy

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Napoli, Italy

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Perugia, Italy

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Ravenna, Italy

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Roma, Italy

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Trento, Italy

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Viterbo, Italy

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Hokkaido, Asahikawa, Japan

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Kashiwa, Chiba, Japan

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Matsuyama, Ehime, Japan

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Yokohama, Kanagawa, Japan

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Tokyo, Koto-ku, Japan

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Sakai, Osaka, Japan

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Sayama, Osaka, Japan

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Sunto-gun, Shizouka, Japan

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Chuo-Ku, Tokyo, Japan

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Gdansk, Poland

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Olsztyn, Poland

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Poznan, Poland

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Warsaw, Poland

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Seoul, South Korea

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Ávila, Spain

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Barcelona, Spain

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Bilbao, Spain

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Cáceres, Spain

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Córdoba, Spain

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Donostia / San Sebastian, Spain

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Las Palmas, Spain

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Madrid, Spain

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Málaga, Spain

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Seville, Spain

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Related Publications (9)

• Pu X, Li J, Zhang B, Zhang J, K Mok TS, Nakagawa K, Rosell R, Cheng Y, Zhou X, Miglorino MR, Niho S, Lee KH, Corral J, Pluzanski A, Li J, Linke R, Pan F, Tang Y, Tan W, Wu L. Efficacy in patients with EGFR-positive non-small-cell lung cancer treated with dacomitinib who had skin adverse events: post hoc analyses from ARCHER 1050. Future Oncol. 2024;20(37):2971-2982. doi: 10.1080/14796694.2024.2404762. Epub 2024 Oct 3.

  PMID: 39360943 DERIVED

• Li J, Nickens D, Wilner K, Tan W. Evaluation of the Effect of Proton Pump Inhibitors on the Efficacy of Dacomitinib and Gefitinib in Patients with Advanced Non-Small Cell Lung Cancer and EGFR-Activating Mutations. Oncol Ther. 2021 Dec;9(2):525-539. doi: 10.1007/s40487-021-00156-2. Epub 2021 Jun 13.

  PMID: 34120312 DERIVED

• Cheng Y, Mok TS, Zhou X, Lu S, Zhou Q, Zhou J, Du Y, Yu P, Liu X, Hu C, Lu Y, Zhang Y, Lee KH, Nakagawa K, Linke R, Wong CH, Tang Y, Zhu F, Wilner KD, Wu YL. Safety and efficacy of first-line dacomitinib in Asian patients with EGFR mutation-positive non-small cell lung cancer: Results from a randomized, open-label, phase 3 trial (ARCHER 1050). Lung Cancer. 2021 Apr;154:176-185. doi: 10.1016/j.lungcan.2021.02.025. Epub 2021 Feb 23.

  PMID: 33721611 DERIVED

• Mok TS, Cheng Y, Zhou X, Lee KH, Nakagawa K, Niho S, Chawla A, Rosell R, Corral J, Migliorino MR, Pluzanski A, Noonan K, Tang Y, Pastel M, Wilner KD, Wu YL. Updated Overall Survival in a Randomized Study Comparing Dacomitinib with Gefitinib as First-Line Treatment in Patients with Advanced Non-Small-Cell Lung Cancer and EGFR-Activating Mutations. Drugs. 2021 Feb;81(2):257-266. doi: 10.1007/s40265-020-01441-6.

  PMID: 33331989 DERIVED

• Corral J, Mok TS, Nakagawa K, Rosell R, Lee KH, Migliorino MR, Pluzanski A, Linke R, Devgan G, Tan W, Quinn S, Wang T, Wu YL. Effects of dose modifications on the safety and efficacy of dacomitinib for EGFR mutation-positive non-small-cell lung cancer. Future Oncol. 2019 Aug;15(24):2795-2805. doi: 10.2217/fon-2019-0299. Epub 2019 Jul 17.

  PMID: 31313942 DERIVED

• Nagano T, Tachihara M, Nishimura Y. Dacomitinib, a second-generation irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) to treat non-small cell lung cancer. Drugs Today (Barc). 2019 Apr;55(4):231-236. doi: 10.1358/dot.2019.55.4.2965337.

  PMID: 31050691 DERIVED

• Mok TS, Cheng Y, Zhou X, Lee KH, Nakagawa K, Niho S, Lee M, Linke R, Rosell R, Corral J, Migliorino MR, Pluzanski A, Sbar EI, Wang T, White JL, Wu YL. Improvement in Overall Survival in a Randomized Study That Compared Dacomitinib With Gefitinib in Patients With Advanced Non-Small-Cell Lung Cancer and EGFR-Activating Mutations. J Clin Oncol. 2018 Aug 1;36(22):2244-2250. doi: 10.1200/JCO.2018.78.7994. Epub 2018 Jun 4.

  PMID: 29864379 DERIVED

• Wu YL, Cheng Y, Zhou X, Lee KH, Nakagawa K, Niho S, Tsuji F, Linke R, Rosell R, Corral J, Migliorino MR, Pluzanski A, Sbar EI, Wang T, White JL, Nadanaciva S, Sandin R, Mok TS. Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial. Lancet Oncol. 2017 Nov;18(11):1454-1466. doi: 10.1016/S1470-2045(17)30608-3. Epub 2017 Sep 25.

  PMID: 28958502 DERIVED

• Ramalingam SS, O'Byrne K, Boyer M, Mok T, Janne PA, Zhang H, Liang J, Taylor I, Sbar EI, Paz-Ares L. Dacomitinib versus erlotinib in patients with EGFR-mutated advanced nonsmall-cell lung cancer (NSCLC): pooled subset analyses from two randomized trials. Ann Oncol. 2016 Mar;27(3):423-9. doi: 10.1093/annonc/mdv593. Epub 2016 Jan 13.

  PMID: 26768165 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung

Interventions

dacomitinib; Gefitinib

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  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: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2013
• First Posted: January 24, 2013
• Study Start: May 9, 2013
• Primary Completion: July 29, 2016
• Study Completion: January 27, 2022
• Last Updated: November 14, 2023
• Results First Posted: October 26, 2018

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

ES (10); KR (1); HK (2); CN (15); JP (9); PL (4); IT (11)