Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Trastuzumab Deruxtecan: Strength: 100 mg powder for concentrate for solution for infusion
Route: Intravenous
Control Intervention1: Pembrolizumab: Strength: 100 mg/ 4ml concentrate for
Sponsors
Daiichi Sankyo, Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Sign and date the Tissue Screening ICF, prior to any Tissue Screening procedure. Sign and date the Main ICF, prior to the start of any trialspecific qualification procedures. Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure, and the Pregnant Partner ICF, if applicable. 2. Adults 18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is 18 years old. 3. Histologically documented non-squamous locally advanced unresectable or metastatic NSCLC and meets all of the following criteria: Has Stage IV NSCLC disease or Stage IIIB or IIIC disease but is not a candidate for surgical resection or definitive chemoradiation at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Has no known AGAs (based on existing test result of local test) that have locally available therapies targeting their AGAs in the first-line advanced/metastatic setting. Has no known HER2 mutation based on existing test results (if approved or validated local test is available). Note: Participants with mixed histology are eligible if adenocarcinoma is the predominant histology. Mixed tumors will be classified based on the predominant cell type. 4. Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. Participants who received adjuvant or neoadjuvant therapy other than those listed below, including ICI (ie, anti-PD-1/PD-L1) or a platinum-based regimen, are eligible if the last dose of adjuvant/neoadjuvant therapy was given at least 6 months before the date of the first trial dose and should not have progressed on or within 6 months of the last dose date of adjuvant/neoadjuvant therapy. a. Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I. b. HER2-targeted antibody-based anticancer therapy. 5. Has adequate tumor tissue sample (not previously irradiated) available for assessment of HER2 and PD-L1 expression by central or Sponsor specified laboratory. A new biopsy is required if the participant s most recent archival tumor tissue sample cannot be supplied. Details pertaining to tumor tissue submission can be found in the Trial Laboratory Manual.
Exclusion criteria
Exclusion criteria: 1. Has a medical history of MI within 6 months before randomization/enrollment or symptomatic CHF (NYHA Class II to Class IV). Participants with troponin levels above the ULN at Screening (as defined by the manufacturer) and without any MI-related symptoms should have a cardiologic consultation during the Screening Period to rule out MI. 2. Has a QTc prolongation to 480 ms based on the average of the Screening triplicate 12- lead ECG. 3. Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening. 4. Has lung-specific, intercurrent, clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.). 5. Had a prior complete pneumonectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival by Blinded Independent Central ReviewTimepoint: Radiographic disease assessments will be performed at baseline, then every 6 weeks ( 7 days) for the first 54 weeks, and every 9 weeks ( 7 days) thereafter until documented radiological progression, death, or study discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall SurvivalTimepoint: From date of randomization to the date of death due to any cause, up to 85 months. | — |
Countries
Argentina, Belgium, Brazil, Chile, China, France, Germany, Greece, Hong Kong, India, Italy, Japan, Malaysia, Mexico, Poland, Portugal, Republic of Korea, Romania, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States of America
Contacts
Public ContactShweta Pradhan
IQVIA RDS (India) Private Limited
Outcome results
None listed