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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 belowSelect...
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
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
420,339 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,287 Previous Clinical Trials
288,619,999 Total Patients Enrolled
Daiichi SankyoLead Sponsor
396 Previous Clinical Trials
418,862 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has a specific genetic change (like EGFR or ALK).I have not taken osimertinib but have been checked for the EGFR T790M mutation after my last treatment.I have no other cancers, or any I had were treated and have been clear for over 3 years.I have or had lung inflammation that needed steroids, or it might be present but not confirmed.I meet the treatment criteria for advanced or metastatic non-small cell lung cancer.My cancer does not have KRAS mutations with other specific genomic changes.I have been treated with drugs targeting topoisomerase I or TROP2.My cancer does not only show high EGFR levels without mutations.My lung cancer has worsened despite recent treatment.You have a disease that can be measured using a specific assessment method.I have severe lung problems due to other lung diseases.My cancer has spread to the lining of my brain and spinal cord.My lung cancer is at an advanced stage (IIIB, IIIC, or IV).I have a serious eye condition affecting my cornea.I can provide a recent tumor biopsy or undergo one for this study.I am an adult and meet the legal age of consent for medical treatment.I do not have active brain metastases requiring steroids or anticonvulsants.I am fully active or can carry out light work.I do not have serious heart problems or uncontrolled high blood pressure.
Research Study Groups:
This trial has the following groups:- Group 1: DS-1062a 6.0 mg/kg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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