Dato-DXd + Pembrolizumab for Lung Cancer

Recruiting in Palo Alto (17 mi)

+24 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Daiichi Sankyo

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study will assess safety and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy in participants with advanced or metastatic non-small cell lung cancer.

Eligibility Criteria

This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) who can't have surgery or chemoradiation. They must have progressed after recent treatment, be able to provide a tumor biopsy, and not have certain genetic alterations in their cancer cells. People with prior severe immune-related side effects from similar drugs, active autoimmune diseases, interstitial lung disease/pneumonitis, other cancers within the last 3 years (with some exceptions), CNS metastases requiring steroids/anticonvulsants are excluded.

Inclusion Criteria

I meet the treatment requirements for advanced lung cancer.

I can provide tissue samples from my initial cancer diagnosis for testing.

My tumor has a KRAS mutation.

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Exclusion Criteria

I have not received a live vaccine in the last 30 days.

I am not on long-term steroids or immunosuppressants, except for side effect management.

I have an autoimmune disease.

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Treatment Details

Interventions

Carboplatin (Alkylating Agent)
Cisplatin (Alkylating Agent)
Datopotamab Deruxtecan (Antibody-Drug Conjugate)
Pembrolizumab (Checkpoint Inhibitor)

Trial OverviewThe study tests Datopotamab Deruxtecan (Dato-DXd) combined with Pembrolizumab and possibly platinum chemotherapy (Carboplatin or Cisplatin). It aims to evaluate the safety and effectiveness of this combination therapy in treating NSCLC that has spread beyond its original site.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Datopotamab deruxtecan (Dato-DXd)Experimental Treatment4 Interventions

Dose Escalation and Dose Expansion: Datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy in participants with advanced or metastatic NSCLC