← Back to Search

Monoclonal Antibodies

DS-1062a for Lung Cancer

Phase 2

Waitlist Available

Research Sponsored by Daiichi Sankyo, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 specified genomic alterations will be excluded

Must not have

Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening

Has prior treatment with any chemotherapeutic agent targeting topoisomerase I, including antibody drug conjugate (ADC) containing such agent, or TROP2-targeted therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline until disease progression, death, or other protocol defined reason, up to approximately 24 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is determining if DS-1062a, a new drug, is effective, safe, and how it is metabolized in patients with NSCLC.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions similar to those seen with other cancer drugs such as fatigue, nausea, inflammation of organs but specifics for DS-1062a will be closely monitored given its novel status.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

My cancer does not have KRAS mutations with other specific genomic changes.

Select...

My cancer does not only show high EGFR levels without mutations.

Select...

My lung cancer has worsened despite recent treatment.

Select...

My lung cancer is at an advanced stage (IIIB, IIIC, or IV).

Select...

I can provide a recent tumor biopsy or undergo one for this study.

Select...

I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

I have severe lung problems due to other lung diseases.

Select...

My cancer has spread to the lining of my brain and spinal cord.

Select...

I have a serious eye condition affecting my cornea.

Select...

I do not have serious heart problems or uncontrolled high blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline until disease progression, death, or other protocol defined reason, up to approximately 24 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline until disease progression, death, or other protocol defined reason, up to approximately 24 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until disease progression, death, or other protocol defined reason, up to approximately 24 months. for reporting.