Rina-S treatment for advanced 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 is an open-label, multicenter Phase 2 trial giving Rina-S as a single agent to about 240 participants with locally advanced or metastatic NSCLC of adenocarcinoma histology. Participants will receive repeated 3-week treatment cycles, with an average treatment duration of about 12 months and 1–5 clinic visits per cycle for safety monitoring, imaging, and blood tests. The trial includes multiple cohorts for participants with or without select genomic alterations and will collect safety, efficacy, pharmacokinetics, and pharmacodynamics data. All enrolled participants receive active drug and must have measurable disease and ECOG performance status 0–1 at enrollment.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Participant has histologically or cytologically confirmed metastatic or locally advanced NSCLC of adenocarcinoma histology, not amenable to curative surgery or radiotherapy.
* Participant must have radiological disease progression while on or after receiving the most recent regimen.
* Participants either may have actionable genetic alterations (AGAs) or no AGAs.
* Participant has measurable disease according to RECIST v1.1.
* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 within 7 days of Cycle 1 Day 1.

Key Exclusion Criteria (all study cohorts):

* Participant has NSCLC with histology other than adenocarcinoma
* Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year OS ≥ 90%), including, but not limited to, adequately treated cervical carcinoma of stage 1B or less, in situ basal cell or squamous cell skin carcinoma, in situ bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥ 3 years.
* Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis (also known as leptomeningeal disease). Participants with history of spinal cord compression (from disease). Participants with previous CNS-directed therapy (eg, radiotherapy and/or surgery) for brain metastases may participate provided lesion(s) are radiologically stable (ie, without evidence of progression) for at least 28 days by repeat imaging.

Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Where it's running

• Compassionate Cancer Care Center
  Fountain Valley, California, United States Recruiting
• City of Hope Orange County Lennar Foundation Cancer Center
  Irvine, California, United States Recruiting
• Kaiser Permanente San Diego Mission Road
  San Diego, California, United States Recruiting
• Providence Medical Foundation (St. Joseph Heritage Healthcare)
  Santa Rosa, California, United States Recruiting
• MedStar Georgetown University Hospital
  Washington D.C., District of Columbia, United States Recruiting
• University of Miami Hospital
  Miami, Florida, United States Recruiting

+52 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Genmab Trial Information
• Email: clinicaltrials@genmab.com
• Phone: +4570202728

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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.