Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 1

NCT05553808 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 205801-0012018-001316-29
• Study Type: interventional
• Target: 105
• Locations: 12 countries
• Sites: 43

Brief Summary

This study is a sub-study of the master protocol 205801 (NCT03739710). This sub study has assessed the clinical activity of novel regimen (Feladilimab plus Docetaxel) with SOC (Docetaxel) in participants with NSCLC.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival was calculated as time from randomization to death. Confidence Intervals estimated using the Brookmeyer Crowley method.

  Up to 2 years

Secondary Outcomes (21)

• Kaplan-Meier Estimates of Overall Survival at 12 and 18 Months

  Month 12 and 18

• Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD) or Not Evaluable

  Up to 2 years

• Kaplan-Meier Estimates of Progression-Free Survival (PFS)

  Up to 2 years

• Objective Response Rate

  Up to 2 years

• Kaplan-Meier Estimates of Duration of Response (DOR) in Participants With Objective Response

  Up to 2 years

Study Arms (2)

Docetaxel

ACTIVE COMPARATOR

Drug: Docetaxel

Feladilimab plus Docetaxel

EXPERIMENTAL

Drug: Docetaxel; Drug: Feladilimab

Interventions

Docetaxel DRUG

Docetaxel was administered as IV infusion.

Docetaxel; Feladilimab plus Docetaxel

Feladilimab DRUG

Feladilimab was administered as IV infusion.

Feladilimab plus Docetaxel

Eligibility Criteria

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

You may qualify if:

• Participants capable of giving signed informed consent/assent.
• Male or female, aged 18 years or older at the time consent is obtained. Participants in Korea must be age 19 years or older at the time consent is obtained.
• Participants with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) and
• a) Documented disease progression based on radiographic imaging, during or after a maximum of 2 lines of systemic treatment for locally/regionally advanced recurrent, Stage IIIb/Stage IIIc/Stage IV or metastatic disease. Two components of treatment must have been received in the same line or as separate lines of therapy: i) No more than or less than 1 line of platinum-containing chemotherapy regimen, and ii) No more than or less than 1 line of Programmed cell death ligand 1 (PD\[L\]1) monoclonal antibody (mAb) containing regimen.
• b) Participants with known BRAF molecular alterations must have had disease progression after receiving the locally available SoC treatment for the molecular alteration.
• c) Participants who received prior anti-PD(L)1 therapy must fulfill the following requirements: i) Have achieved a CR, PR or SD and subsequently had disease progression (per RECIST 1.1 criteria) either on or after completing PD(L)1 therapy ii) Have not progressed or recurred within the first 12 weeks of PD(L)1 therapy, either clinically or per RECIST 1.1 criteria
• Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
• A tumor tissue sample obtained at any time from the initial diagnosis of NSCLC to time of study entry is mandatory. Although a fresh tumor tissue sample obtained during screening is preferred, archival tumor specimen is acceptable.
• Adequate organ function as defined in the protocol.
• A male participant must agree to use a highly effective contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions apply:
• i) Not a woman of childbearing potential (WOCBP) or ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
• Life expectancy of at least 12 weeks.

You may not qualify if:

• Participants who received prior treatment with the following therapies (calculation is based on date of last therapy to date of first dose of study treatment):
• Docetaxel at any time.
• Any of the investigational agents being tested in the current study.
• Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered.
• Prior radiation therapy: permissible if at least one non-irradiated measurable lesion is available for assessment per RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least 2 weeks before start of study drug for radiation of any intended use is required.
• Received greater than (\>)2 prior lines of therapy for NSCLC, including participants with BRAF molecular alternations.
• Invasive malignancy or history of invasive malignancy other than disease under study within the last 2 years, except
• Any other invasive malignancy for which the participant was definitively treated, has been disease-free for at least 2 years and in the opinion of the principal investigator and GlaxoSmithKline Medical Monitor will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy, may be included in this clinical trial.
• Curatively treated non-melanoma skin cancer or successfully treated in situ carcinoma.
• Carcinomatous meningitis (regardless of clinical status) and uncontrolled or symptomatic Central nervous system (CNS) metastases.
• Major surgery less than or equal to (\<=) 28 days of first dose of study treatment.
• Autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years. Replacement therapies which include physiological doses of corticosteroids for treatment of endocrinopathies (for example, adrenal insufficiency) are not considered systemic treatments.
• Receiving systemic steroids (\>10 milligrams \[mg\]) oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to first dose of study treatment.
• Prior allogeneic/autologous bone marrow or solid organ transplantation.
• Receipt of any live vaccine within 30 days prior to first dose of study treatment.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• iTeos Belgium SA: collaborator

Study Sites (43)

GSK Investigational Site

St Louis, Missouri, 63110-1093, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37203, United States

Location

GSK Investigational Site

Dallas, Texas, 75230, United States

Location

GSK Investigational Site

Toronto, Ontario, M5G 2M9, Canada

Location

GSK Investigational Site

Bordeaux, 33076, France

Location

GSK Investigational Site

Caen, 14033, France

Location

GSK Investigational Site

Nantes, 44093, France

Location

GSK Investigational Site

Paris, 75018, France

Location

GSK Investigational Site

Paris, 75248, France

Location

GSK Investigational Site

Villejuif, 94805, France

Location

GSK Investigational Site

Gauting, Bavaria, Germany

Location

GSK Investigational Site

Immenhausen, Hesse, 34376, Germany

Location

GSK Investigational Site

Leipzig, Saxony, Germany

Location

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

GSK Investigational Site

Berlin, 14165, Germany

Location

GSK Investigational Site

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

Location

GSK Investigational Site

Ravenna, Emilia-Romagna, 48121, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20133, Italy

Location

GSK Investigational Site

Orbassano (TO), Piedmont, 10043, Italy

Location

GSK Investigational Site

Maastricht, 6229 HX, Netherlands

Location

GSK Investigational Site

Lodz, 93-513, Poland

Location

GSK Investigational Site

Poznan, 60-569, Poland

Location

GSK Investigational Site

Warsaw, 02-781, Poland

Location

GSK Investigational Site

Bucharest, 020142, Romania

Location

GSK Investigational Site

Craiova, 200347, Romania

Location

GSK Investigational Site

Floreşti, 407280, Romania

Location

GSK Investigational Site

Otopeni, 075100, Romania

Location

GSK Investigational Site

Timișoara, 300166, Romania

Location

GSK Investigational Site

Chelyabinsk, 454048, Russia

Location

GSK Investigational Site

Saint Petersburg, 194291, Russia

Location

GSK Investigational Site

Saint Petersburg, 197183, Russia

Location

GSK Investigational Site

Cheongju-si, 28644, South Korea

Location

GSK Investigational Site

Gyeonggi-do, 10408, South Korea

Location

GSK Investigational Site

Seongnam, 13620, South Korea

Location

GSK Investigational Site

Seoul, 05505, South Korea

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Barcelona, 08036, Spain

Location

GSK Investigational Site

Madrid, 28027, Spain

Location

GSK Investigational Site

Madrid, 28033, Spain

Location

GSK Investigational Site

Madrid, Spain

Location

GSK Investigational Site

Santander, 39008, Spain

Location

GSK Investigational Site

Seville, 41009, Spain

Location

GSK Investigational Site

Uppsala, SE- 75 185, Sweden

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: January 24, 2019
• Primary Completion: September 23, 2021
• Study Completion: September 23, 2021
• Last Updated: January 19, 2023
• Results First Posted: January 19, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

NL (1); DE (5); PL (3); CA (1); US (3); FR (6); SE (1); ES (7); IT (4); RO (5); RU (3); KR (4)