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) with evidence of stage IV disease.
No known actionable genomic alterations for which approved therapies are available.
Eastern cooperative oncology group (ECOG) performance status score of 0 or 1.
Measurable disease as per response evaluation criteria in solid tumors (RECIST) 1.1 criteria.
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
For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative.
No prior systemic treatment for metastatic NSCLC.
Substudy 02: All Experimental arms
In individuals with nonsquamous histology, individuals with EGFR, ALK, or any other known actionable genomic alterations must have received treatment with at least 1 approved tyrosine kinase inhibitor (TKI) appropriate to the genomic alteration.
Progression or disease recurrence after platinum-based chemotherapy with anti-PD-1 or anti-PD-L1 antibody OR sequential treatment (in any order).
Key Exclusion Criteria:
All Substudies:
Mixed small-cell lung cancer and NSCLC histology.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Received previous anticancer therapy within 4 weeks prior to enrollment.
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.
Note: Other protocol defined inclusion/exclusion criteria may apply
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There are 12 Locations for this study
Tucson Arizona, 85711, United States
Tucson Arizona, 85711, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Cincinnati Ohio, 45242, United States
Cincinnati Ohio, 45242, United States
Austin Texas, 78745, United States
Austin Texas, 78745, United States
Fairfax Virginia, 22031, United States
Fairfax Virginia, 22031, United States
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Cheongju-si , 28644, Korea, Republic of
Cheongju-si , 28644, Korea, Republic of
Goyang , 41076, Korea, Republic of
Goyang , 41076, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 463-7, Korea, Republic of
Seoul , 463-7, Korea, Republic of
Changhua City , 500-0, Taiwan
Changhua City , 500-0, Taiwan
Kaohsiung , 83301, Taiwan
Kaohsiung , 83301, Taiwan
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