DS-3939a in solid tumors and non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This two-substudy trial explores DS-3939a in combination with immunotherapy and other agents for locally advanced unresectable or metastatic non-squamous NSCLC, as well as DS-3939a as a monotherapy or with DS-1103a in similar disease. It features a dose-escalation phase to identify safe dosing, followed by a dose-expansion phase to better understand efficacy signals. Part 1 assignments are non-randomized, while Part 2 uses randomization in both substudies. Interventions include DS-3939a, pembrolizumab, carboplatin, pemetrexed, and DS-1103a, with eligibility focusing on adults with specific NSCLC stages and adequate organ function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Sign and date the Main Trial informed consent form (ICF), prior to the start of any trial-specific procedures.
2. Adults greater than or equal to (≥)18 years of age at the time the Main Trial ICF is signed (follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old).
3. Histologically documented Stage IIIB, IIIC disease who is not candidate for surgical resection or definitive chemoradiation, or Stage IV NSQ NSCLC.
4. Has a left ventricular ejection fraction (LVEF) ≥50 percent (%) by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days of the first trial intervention.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 assessed no more than 14 days prior to initiation of trial interventions.
6. Has adequate organ function.
7. Participants must have measurable disease by investigator assessment according to RECIST v1.1.

Additional Inclusion Criteria for Substudy 1:

1\. Participants must not have received prior systemic therapy for locally advanced unresectable or metastatic NSCLC.

Additional Inclusion Criteria for Substudy 2:

1. Participants with AGA (excluding EGFR mutation): Participants have been previously treated with targeted therapy for the AGA and platinum-based chemotherapy for the advanced disease setting.
2. Participants without AGA: Participants have been previously treated with platinum-based chemotherapy and anti-programmed death-1 (anti-PD-1)/programmed death-ligand 1 (PD-L1) antibody
3. Part 2 only: Participants must have received only 1 or 2 prior lines of anticancer therapy for the advanced disease setting.

Exclusion Criteria:

1. Prior systemic anticancer therapy targeting MUC1 or TA-MUC1.
2. Prior systemic anticancer therapy with topoisomerase 1 inhibitor or topoisomerase 1 inhibitor-based antibody-drug conjugate (ADCs) (e.g., datopotamab deruxtexan and Sacituzumab govitecan).
3. Has spinal cord compression or clinically active central nervous system (CNS) metastases.
4. Has multiple primary malignancies.
5. Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening
6. Has active or uncontrolled human immunodeficiency virus (HIV) infection.
7. Has active or uncontrolled hepatitis B virus (HBV)/hepatitis C virus (HCV) infection.
8. Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
9. Current participation in other therapeutic investigational procedures, except for participation in long term survival follow-up (LTSFU) without any investigational treatment.

Where it's running

• Highlands Oncology Group (Hog) - Fayetteville
  Fayetteville, Arkansas, United States Recruiting
• Inova Schar Cancer Institute
  Fairfax, Virginia, United States Recruiting
• Kansai Medical University Hospital
  Hirakata, Japan Recruiting
• UCLA Health
  Los Angeles, California, United States Not yet recruiting
• Moffitt Cancer Center - Magnolia Campus
  Tampa, Florida, United States Not yet recruiting
• Oregon Health & Science University
  Portland, Oregon, United States Not yet recruiting

+26 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Daiichi Sankyo Contact for Clinical Trial Information
• Email: CTRinfo_us@daiichisankyo.com
• Phone: 9089926400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.