Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)

Inclusion Criteria

• •Sign and date the inform consent form (ICF) prior to the start of any study- specific qualification procedures.
• •Adults ≥18 years (if the legal age of consent is \>18 years old, then follow local regulatory requirements)
• •Has pathologically documented NSCLC that:
• •1. Has stage IIIB, IIIC, or stage IV NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition).
• •2. Has one or more of the following documented activating genomic alterations: EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET.
• •KRAS mutations in the absence of any of the genomic alterations specified above will be excluded.
• •Overexpression of EGFR, in the absence of activating mutations, is NOT sufficient for enrollment.
• •Participants who have not received osimertinib should be evaluated for the presence of EGFR T790M mutation after relapse/progression on/after the most recent EGFR tyrosine kinase inhibitor (TKI), unless the participant is already known to be positive with document results for this mutation or unless osimertinib is not locally approved.
• •Has documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
• •Participant must meet the following for advanced or metastatic NSCLC:
• •1. Has been treated with at least one but no more than two cytotoxic agent-containing therapy in the metastatic setting:
• •* One platinum-containing regimen (either as monotherapy or combination therapy).
• •* May have received up to one additional line of cytotoxic agent-containing therapy.
• •* Those who received a platinum-containing regimen as adjuvant therapy for early stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose OR received at least one additional course of platinum-containing therapy (which may or may not be same as in the adjuvant setting) for relapsed/progressive disease.
• •2. May have received up to one checkpoint inhibitor (CPI)-containing regimen (may be in combination with a cytotoxic agent as part of a regimen described above or as an additional CPI regimen without a cytotoxic agent).
• •3. Has been treated with 1 or more lines of non-CPI targeted therapy that is locally approved for the participant's applicable genomic alteration at the time of screening:
• •* Those who received a targeted agent for the applicable genomic alterations in the study as adjuvant therapy for early stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose OR received at least one additional course of targeted therapy for the same genomic alterations (which may or may not be same agent used in the adjuvant setting) for relapsed/progressive disease.
• •* Participants who have been treated with a prior TKI must receive additional targeted therapy, if clinically appropriate, for the genomic alterations that are considered amenable or the participant will not be allowed in the study.
• •Must undergo a mandatory pre-treatment tumor biopsy procedure or if available, a tumor biopsy that was recently collected (within 3 months of screening) after completion of the most recent anticancer treatment regimen and that has a minimum of 10 × 4 micron sections or a tissue block equivalent of 10 × 4 micron sections may be substituted for the mandatory biopsy collected during screening.
• •Measurable disease based on local imaging assessment using RECIST v1.1.
• •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 - 1 at screening.