NCT07154368Not yet recruitingPhase 3
JYP0322 Versus Platinum Based Doublet Chemotherapy in ROS1 Positive Patients Previously Treated With ROS1-TKIs.
A Randomized, Open-Label, Multicenter, Phase 3 Study Evaluating the Efficacy and Safety of JYP0322 Versus Platinum-Based Chemotherapy in ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer Patients Previously Treated With ROS1-TKI Therapy.
Source: ClinicalTrials.gov · Last updated 19 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The primary purpose of the study was to compare progression-free survival of JYP0322 vs. platinum-based doublet chemotherapy in patients previously treated with ROS1-TKIs. Patients in the chemotherapy arm are given the option to switch to JYP0322 after BICR confirmed progressive disease (PD), while also have the choice to pursue with other drugs after discussing with their physicians.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 207 (estimated)
- First submitted
- 19 Aug 2025
- Start date
- 23 Sept 2025
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Guangzhou JOYO Pharma Co., Ltd
- Diseases
- Lung cancer
- NCT number
- NCT07154368
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 207
- From 23 Sept 2025 to the primary completion date, 31 Oct 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Key Exclusion Criteria:
- Current participation in another therapeutic clinical trial.
- Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.
- A history of severe allergies, or a history of severe allergy, hypersensitivity or other hypersensitivity to any active or inactive ingredient of the study drug.
- All acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade more than 1.
- Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
- Known active infe
Who the study is looking for
- Key Inclusion Criteria
- Subjects with histologically or cytologically documented NSCLC.
- Locally advanced or metastatic ROS1 fusion positive NSCLC.
- Prior one or two ROS1-TKI(s) Treatment.
- World Health Organization (WHO) performance status 0-1.
- Life expectancy of at least 3 months.
- At least one measurable lesion according to RECISIT 1.1.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.