Study of Novel Treatment Combinations in Patients With Lung Cancer

Sponsor: Gilead Sciences

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05633667

Patient View

This platform trial evaluates novel treatment combinations in NSCLC. Eligibility includes documented NSCLC, ECOG 0-1, and no actionable genomic alterations. Substudy-01 targets untreated metastatic NSCLC, Substudy-02 involves post-treatment progression, and Substudy-03 focuses on resectable stages. Interventions include Zimberelimab, Domvanalimab, and others, administered intravenously or orally.

Patient Parameters

Program Overview

The goal of this platform clinical trial is to test how well novel treatment combinations work in participants with lung cancer. Substudy-01 will compare the different novel combinations versus standard of care in participants with metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC) who have not been treated before. Substudy-02 will compare the different novel combination versus standard of care in participants with cancer that has progressed after receiving previous treatment for metastatic NSCLC. Substudy-03 will compare the different novel combinations versus standard of care in participants with resectable stage II-III NSCLC.

The primary objectives of this study are:

Substudy-01 and Substudy-02: To evaluate the objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

Substudy-03: To evaluate the efficacy of treatment combinations based on complete pathological response (pCR) rate.

Eligibility Criteria

Inclusion Criteria

All Substudies:

  • Histologically or cytologically documented non-small-cell lung cancer (NSCLC).
  • No known actionable genomic alterations for which targeted therapies are available.
  • Eastern cooperative oncology group (ECOG) performance status score of 0 or 1.
  • Measurable disease per response evaluation criteria in solid tumors.
  • Adequate hematologic and end-organ function.
  • Individuals of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception.

Substudy 01: All Experimental arms

  • Stage IV NSCLC.
  • For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative.
  • PD-L1 status by central confirmation.
  • No prior systemic treatment for metastatic NSCLC.

Substudy 02: All Experimental arms

  • Stage IV NSCLC.
  • In individuals with nonsquamous histology and actionable EGFR, ALK, or other known genomic alterations must have received treatment with at least 1 targeted therapy to the appropriate genomic alteration.

Substudy 03: All Experimental arms

  • Previously untreated individuals with resectable (Stage II, IIIA, IIIB (T[3-4]N2) NSCLC (per American Joint Committee on Cancer (AJCC) Edition 8).
  • Planned surgery must comprise of lobectomy, sleeve lobectomy, or bi-lobectomy.
  • PD-L1 status by central confirmation.
  • For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative.

Key

Exclusion Criteria

All Substudies:

  • Mixed small-cell lung cancer and NSCLC histology.
  • Active second malignancy.
  • Active autoimmune disease.
  • History of or current non-infectious pneumonitis/interstitial lung disease.
  • Active serious infection within 4 weeks prior to study treatment.

Substudy 01 and 02

  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Received previous anticancer therapy within 4 weeks prior to enrollment.

Substudy 03: All Experimental arms

  • NSCLC previously treated with systemic therapy or radiotherapy.
  • Received prior treatment with any anti-PD-(L)-1 or other immune checkpoint inhibitors (CPIs).

Note: Other protocol defined inclusion/exclusion criteria may apply

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