Lung Cancer Clinical Trial
Study of Novel Treatment Combinations in Patients With Lung Cancer
Summary
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 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. New substudies and/or treatment arms may be added to the study through amendment of the master protocol and/or substudy protocols.
Eligibility Criteria
Key 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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There are 28 Locations for this study
Tucson Arizona, 85711, United States
Tucson Arizona, 85711, United States
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
Fort Wayne Indiana, 46845, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Cincinnati Ohio, 45242, United States
Cincinnati Ohio, 45242, United States
Eugene Oregon, 97401, United States
Eugene Oregon, 97401, United States
Austin Texas, 78745, United States
Austin Texas, 78745, United States
Fairfax Virginia, 22031, United States
Fairfax Virginia, 22031, United States
Seattle Washington, 98109, United States
Seattle Washington, 98109, United States
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
New Territories , , Hong Kong
Haifa , 35254, Israel
Haifa , 35254, Israel
Haifa , 35254, Israel
Jerusalem , 91031, Israel
Jerusalem , 91031, Israel
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Tel Aviv-Yafo , 64239, Israel
Tel Aviv-Yafo , 64239, Israel
Tel Aviv-Yafo , 64239, Israel
Cheongju-si , 28644, Korea, Republic of
Cheongju-si , 28644, Korea, Republic of
Goyang , 41076, Korea, Republic of
Goyang , 41076, Korea, Republic of
Goyang , 41076, Korea, Republic of
Gwangju , 61469, Korea, Republic of
Gyeonggi-do , 463-7, Korea, Republic of
Seo-gu , 49267, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Seoul , 463-7, Korea, Republic of
Seoul , 463-7, Korea, Republic of
Seoul , 8308, Korea, Republic of
Changhua City , 500-0, Taiwan
Changhua City , 500-0, Taiwan
Changhua City , 500-0, Taiwan
Kaohsiung City , 80756, Taiwan
Kaohsiung City , 80756, Taiwan
Kaohsiung City , 80756, Taiwan
Kaohsiung , 83301, Taiwan
Kaohsiung , 83301, Taiwan
Kaohsiung , 83301, Taiwan
Taipei City , 100, Taiwan
Taipei City , 100, Taiwan
Birmingham , B9 5S, United Kingdom
Birmingham , B9 5S, United Kingdom
London , E1 1B, United Kingdom
London , E1 1B, United Kingdom
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