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Antibody-Drug Conjugate

Dato-DXd + Pembrolizumab for Lung Cancer

Phase 1
Waitlist Available
Research Sponsored by Daiichi Sankyo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with tumors that harbor KRAS mutations are eligible for this study
Has adequate bone marrow reserve and organ function at baseline within 7 days prior to Cycle 1 Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 30 months post-dose
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a new cancer drug when used alone or with another drug and chemotherapy.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site, fatigue, nausea, hair loss from chemotherapy; immune-related issues like inflammation of organs due to Pembrolizumab; and possible damage to normal cells by Dato-DXd.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor has a KRAS mutation.
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My organs and bone marrow are working well.
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My lung cancer has worsened despite my last treatment.
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My cancer does not have known mutations in key genes like ROS1 or BRAF.
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I am willing and able to have a tumor biopsy.
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My lung cancer is confirmed to be advanced or has spread.
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Surgery or chemoradiation cannot cure my condition.
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My non-squamous cancer tests negative for EGFR and ALK changes.
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My cancer has specific genetic changes that are not targeted by current treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 30 months post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 30 months post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Dose-limiting Toxicities (DLTs) and Treatment-emergent Adverse Events (TEAEs)
Secondary outcome measures
Anti-drug Antibodies for Dato-DXd and Pembrolizumab
Duration of Response
Objective Response Rate
+5 more

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KEYTRUDA®
2018
Completed Phase 2
~70
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,287 Previous Clinical Trials
288,620,005 Total Patients Enrolled
Daiichi SankyoLead Sponsor
396 Previous Clinical Trials
418,854 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,907 Previous Clinical Trials
5,065,951 Total Patients Enrolled

Media Library

Lung Cancer Research Study Groups: Datopotamab deruxtecan (Dato-DXd)
~28 spots leftby Jun 2025
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