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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

Must not have

Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications, except for managing AEs

Active, known, or suspected autoimmune disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1, day 1: pre-dose, 30 minutes, 3 hours, 5 hours, and 7 hours post-dose; cycles 1 and 3, day 2, day 4, day 8, and day 15; cycles 2-4, cycle 6, and cycle 8, day 1: pre-dose and post-dose (each cycle is 21 days)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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

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I have an autoimmune disease.

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I have severe lung problems due to other lung diseases.

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I have had an organ or tissue transplant.

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I had severe side effects from previous immunotherapy.

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I have or had lung inflammation that needed steroids, or it might be seen in my scans.

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I have spinal or brain metastases needing steroids or anticonvulsants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1, day 1: pre-dose, 30 minutes, 3 hours, 5 hours, and 7 hours post-dose; cycles 1 and 3, day 2, day 4, day 8, and day 15; cycles 2-4, cycle 6, and cycle 8, day 1: pre-dose and post-dose (each cycle is 21 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 1, day 1: pre-dose, 30 minutes, 3 hours, 5 hours, and 7 hours post-dose; cycles 1 and 3, day 2, day 4, day 8, and day 15; cycles 2-4, cycle 6, and cycle 8, day 1: pre-dose and post-dose (each cycle is 21 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1, day 1: pre-dose, 30 minutes, 3 hours, 5 hours, and 7 hours post-dose; cycles 1 and 3, day 2, day 4, day 8, and day 15; cycles 2-4, cycle 6, and cycle 8, day 1: pre-dose and post-dose (each cycle is 21 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) of Dato-DXd, Total Anti-TROP2 Antibody, and MAAA-1181a

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~6120