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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 30 months post-dose

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

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Daiichi SankyoLead Sponsor

392 Previous Clinical Trials

411,220 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,426 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,257 Previous Clinical Trials

288,593,641 Total Patients Enrolled

Media Library

Lung Cancer Research Study Groups: Datopotamab deruxtecan (Dato-DXd)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare centers are currently participating in the trial?

"This clinical trial is being conducted out of the Johns Hopkins Kimmel Cancer Center in Washington, DC; The Skip Viragh Outpatient Building in Baltimore, MD; and City of Hope located in Scottsdale, Arizona. There are 7 other sites that are also participating."

Answered by AI

Are new individuals being accepted into this clinical experiment currently?

"According to clinicaltrials.gov, this scientific inquiry is actively looking for participants. This project was initially uploaded on September 15th 2020 and its details were recently revised on October 6th 2022."

Answered by AI

Has the Food and Drug Administration granted authorization for Datopotamab deruxtecan?

"With a score of 1, our team at Power believes that datopotamab deruxtecan has limited clinical data regarding efficacy and safety due to its being in the initial phase of medical trials."

Answered by AI

Is there evidence of past examinations involving Datopotamab deruxtecan?

"Datopotamab deruxtecan was first researched in 1997 at City of Hope Comprehensive Cancer Center, and the number of completed clinical trials has now grown to 1866. Currently, 1944 studies are actively recruiting volunteers; a good portion of these are located in Washington D.C.."

Answered by AI

What therapeutic indications is Datopotamab deruxtecan used for?

"Datopotamab deruxtecan is typically utilized to treat malignant neoplasms, however it may also be prescribed for patients with unresectable melanoma, microsatellite instability high and a heightened risk of relapse."

Answered by AI

What is the total participant capacity for this research endeavor?

"A total of 140 participants with the established eligibility requirements must join this trial which is being held at multiple locations; among them include Johns Hopkins Kimmel Cancer Center in Washington, DC and The Skip Viragh Outpatient Cancer Building in Baltimore, Maryland."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Datopotamab Deruxtecan (Dato-DXd) in Combination With Pembrolizumab With or Without Platinum Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung02)

2020. "Datopotamab Deruxtecan (Dato-DXd) in Combination With Pembrolizumab With or Without Platinum Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung02)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04526691.

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