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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to approximately 24 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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

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

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

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My lung cancer has worsened despite recent treatment.

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

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

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR)

Secondary outcome measures

Duration of Response (DOR)

Overall Survival (OS)

Percentage of Participants Who Reported Treatment-emergent Adverse Events (TEAE)

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: DS-1062a 6.0 mg/kgExperimental Treatment1 Intervention

Participants will receive 6.0 mg/kg of DS-1062a

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Daiichi Sankyo, Inc.Lead Sponsor

389 Previous Clinical Trials

415,160 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,259 Previous Clinical Trials

288,593,765 Total Patients Enrolled

Daiichi SankyoLead Sponsor

392 Previous Clinical Trials

411,228 Total Patients Enrolled

Media Library

DS-1062a (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04484142 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: DS-1062a 6.0 mg/kg

Non-Small Cell Lung Cancer Clinical Trial 2023: DS-1062a Highlights & Side Effects. Trial Name: NCT04484142 — Phase 2

DS-1062a (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04484142 — Phase 2

Frequently Asked Questions

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

Are there any new opportunities to participate in this medical trial?

"The clinicaltrials.gov website states that this specific trial, which commenced on March 30th 2021 and was last modified on November 29th 2022, is no longer recruiting patients; however, there are 1956 other trials actively sourcing participants at the moment."

Answered by AI

Are there any supplemental investigations pertaining to DS-1062a?

"Currently, there are 8 active studies researching DS-1062a with 2 in their final phase of testing. Of these sites, 658 exist across Shandong and Illinois."

Answered by AI

How many participants are engaged in this clinical research?

"Currently, this research endeavour is not recruiting any more participants. Initially posted on March 30th 2021 and last edited November 29th 2022, other studies may be of interest to you; 1948 clinical trials for lung cancer are actively seeking participants, as well as 8 experiments involving DS-1062a."

Answered by AI

How many sites are actively managing this research endeavor?

"29 medical centres have been enlisted to facilitate this trial, including renowned institutions such as the Mayo Clinic in Jacksonville and Avera Cancer Institute Sioux Falls. Additionally, Mary Crowley Cancer Research of Dallas is one other notable site that has signed up for participation."

Answered by AI

Has DS-1062a received regulatory endorsement from the FDA?

"Although there is limited information about the efficacy of DS-1062a, our team gave it a rating of 2 based on existing data regarding its safety."

Answered by AI

Is this experiment a pioneering venture in the medical field?

"Presently, 8 trials exploring the potential efficacy of DS-1062a are taking place in 140 cities and 28 nations. Sponsored by Daiichi Sankyo, Inc., this medication underwent its first clinical trial back in 2018 with a cohort size of 770 people. Since then, no studies have been conducted regarding this substance's suitability as an approved drug."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)

2021. "Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04484142.

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