DS-1062a for Lung Cancer

Recruiting in Palo Alto (17 mi)

+85 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Daiichi Sankyo, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a study of the efficacy, pharmacokinetics, and safety of DS-1062a in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with known actionable genomic alterations.

Eligibility Criteria

Adults over 18 with advanced or metastatic non-small cell lung cancer (NSCLC) and specific genomic alterations like EGFR, ALK, ROS1 can join. They must have measurable disease progression after recent treatment and be in good physical condition (ECOG PS of 0-1). Those with certain heart conditions, prior treatments targeting topoisomerase I or TROP2, active brain metastases requiring steroids/anticonvulsants, severe lung issues like ILD/pneumonitis are excluded.

Inclusion Criteria

My cancer has a specific genetic change (like EGFR or ALK).

I have not taken osimertinib but have been checked for the EGFR T790M mutation after my last treatment.

I meet the treatment criteria for advanced or metastatic non-small cell lung cancer.

+9 more

Exclusion Criteria

I have no other cancers, or any I had were treated and have been clear for over 3 years.

I have or had lung inflammation that needed steroids, or it might be present but not confirmed.

I have been treated with drugs targeting topoisomerase I or TROP2.

+5 more

Participant Groups

The trial is testing DS-1062a's effectiveness and safety for NSCLC patients with actionable genetic changes. It will assess how the body processes the drug and monitor any improvements in cancer symptoms or size.

1Treatment groups

Experimental Treatment

Group I: DS-1062a 6.0 mg/kgExperimental Treatment1 Intervention

Participants will receive 6.0 mg/kg of DS-1062a