NSCLC (Advanced Non-small Cell Lung Cancer)Phase 3NCT07816380
A Phase III Study to Evaluate the Efficacy and Safety of JYP0322 in Previously Untreated ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 3 study testing JYP0322 Tablets and Crizotinib Capsules in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Guangzhou JOYO Pharma Co., Ltd.
Trial summary
This is a randomized, open-label, multicenter phase III study to evaluate the efficacy and safety of JYP0322 compared with crizotinib in previously untreated ROS1-positive locally advanced or metastatic non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Advanced Non-small Cell Lung Cancer)
- What is being tested?
- JYP0322 Tablets and Crizotinib Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 30 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation and signed written informed consent (ICF) before any study-specific procedure.
- Age ≥ 18 years at screening. Histologically or cytologically confirmed, unresectable locally advanced (AJCC 9th edition stage IIIB or IIIC not amenable to multimodality therapy) or metastatic (stage IV) ROS1-positive non-small cell lung cancer (NSCLC).
- ROS1 gene rearrangement/fusion positivity confirmed by a qualified local laboratory using PCR, NGS, or FISH. IHC alone is not acceptable. A written report of the ROS1 test must be provided.
- Sufficient and adequate archival tumor tissue must be available for central laboratory ROS1 retesting per the Central Lab Manual; if no archival tissue is available, a fresh tumor biopsy is required.
- No prior ROS1 TKI therapy. Prior systemic therapy limited to ≤1 line of standard chemotherapy:
- A prior chemotherapy-based regimen administered for ≥1 cycle counts as one line.
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- Disease recurrence within 6 months after completion of adjuvant chemotherapy counts that adjuvant regimen as one prior line.
- Asymptomatic central nervous system (CNS) metastases allowed (leptomeningeal carcinomatosis excluded). Previously treated and controlled/stabilized CNS metastases permitted if:
- On non-enzyme-inducing antiepileptic drugs (non-EIAED) for seizure prophylaxis; or EIAED discontinued ≥14 days before randomization.
- If corticosteroids needed, stable or tapering dose ≤10 mg/day prednisone (or equivalent) for ≥14 days before randomization.
- Prior local therapy (WBRT, SRS/SRT) completed ≥14 days before randomization; treatment-related toxicities (except alopecia) resolved to ≤ Grade 1 (CTCAE v5.0).
- At least one measurable lesion per RECIST v1.1. ECOG performance status 0-1. Expected survival ≥ 3 months.
- Adequate organ function within 14 days before randomization (no blood products, growth factors, or platelet/ WBC boosters within 14 days):
- ANC ≥ 1.5 × 10^9/L
- Platelets ≥ 100 × 10^9/L
- Hemoglobin ≥ 90 g/L (stable erythropoietin ≥3 months allowed)
- CrCl > 45 mL/min (Cockcroft-Gault)
- Total bilirubin < 1.5 × ULN (Gilbert syndrome ≤ 3.0 × ULN)
- AST and ALT < 2.5 × ULN (< 5 × ULN if liver metastasis)
- APTT and INR < 1.5 × ULN Women of childbearing potential: negative serum pregnancy test within 7 days before randomization. All participants with reproductive potential (male and female) must agree to use highly effective contraception (hormonal, barrier, or abstinence) during treatment and for 6 months after last dose. Willing and able to comply with scheduled visits, treatment, labs, and procedures.
Who cannot join
- History of severe cardiovascular or cerebrovascular disease, including but not limited to: clinically significant cardiac rhythm or conduction abnormality (e.g., ventricular arrhythmia requiring intervention, 2nd-3rd degree AV block); acute coronary syndrome, congestive heart failure, aortic dissection, severe stable/unstable angina, coronary/peripheral vascular intervention, stroke or other ≥Grade 3 cerebrovascular event (including TIA), pulmonary embolism, DVT or other clinically significant thrombosis within 6 months before randomization; NYHA > Class II heart failure or LVEF < 50%; any uncontrolled atrial fibrillation; QTcF > 470 ms or symptomatic bradycardia < 45 bpm; known congenital long QT syndrome or history of QT prolongation.
- Active infection requiring IV antibiotics or hospitalization at randomization. Acute flare of dysphagia or GI disease affecting absorption (Crohn's, UC, short bowel syndrome, or other malabsorption).
- Failure to recover from prior antitumor therapy toxicity to baseline or ≤Grade 1 (CTCAE v5.0), except alopecia, Grade 2 peripheral neuropathy, or hypothyroidism controlled by replacement judged safe by investigator.
- Major surgical procedure (other than dx/biopsy/drainage) within 4 weeks before randomization, or anticipated major surgery during study; vascular access placement and minor procedures (catheter, core needle biopsy) allowed.
- Other primary malignancy except: adequately treated melanoma/skin carcinoma/cervical carcinoma in situ; treated non-metastatic prostate cancer; or other primary malignancy with no relapse ≥3 years.
- Untreated spinal cord compression by tumor. Participated in another interventional trial within 4 weeks before first dose (screen failures exempt).
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- Interstitial fibrosis, ILD, or drug-induced pneumonitis within 6 months before first dose not recovered to Grade 1 (asymptomatic radiation pneumonitis exempt).
- Systemic anticancer therapy (chemo-based or other) within 14 days or 5 half-lives (whichever shorter, minimum 14 days) before randomization.
- Clinically uncontrolled serous effusion needing drainage > once/month (pericardial/pleural/ascites), or < 2 weeks observation after last drainage before randomization.
- History of severe allergy or hypersensitivity to JYP0322 or crizotinib excipients.
- Active HBV (HBsAg+ and HBV DNA ≥1000 IU/mL or 5000 copies/mL), active HCV (RNA+), syphilis requiring treatment (RPR ≤1:2 with TPHA+ allowed), or HIV infection.
- Pregnant or lactating. Use of strong CYP3A4 inhibitors/inducers or narrow-therapeutic-index CYP3A4 substrates within 14 days or 5 half-lives (shorter) before randomization, or inability to discontinue during study.
- Active or recurrent autoimmune disease, depression/affective disorder or suicidal risk, prior bone marrow/organ transplant, or any condition investigator judges unsafe.
- Uncontrolled hyperthyroidism or hypothyroidism with prior severe comorbidity. Moderate-to-severe hepatic impairment history: prior ≥Grade 3 hepatotoxicity, or serious liver baseline (cirrhosis etc.).
- Tumor invasion of great vessels (aorta, pulmonary artery/vein, vena cava) on imaging; OR any prior TKI therapy including ROS1-TKI.
About this study
Official title: A Randomized, Open-Label, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of JYP0322 Versus Crizotinib in Previously Untreated ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This is a randomized, open-label, multicenter phase III study to evaluate the efficacy and safety of JYP0322 compared with crizotinib in previously untreated ROS1-positive locally advanced or metastatic non-small cell lung cancer.
- Being tested
- JYP0322 Tablets, Crizotinib Capsules
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JYP0322 TabletsDrug
Oral administration, 150 mg each dose, three times daily (TID), continuous dosing.
Crizotinib CapsulesDrug
Oral administration, 250 mg twice daily (BID), continuous dosing.
| Study group | Role | What they receive |
|---|---|---|
| JYP0322 Tablets | Experimental | Not described Receives: Drug: JYP0322 Tablets |
| Crizotinib Capsules | Active comparator | Not described Receives: Drug: Crizotinib Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR/BIRC) per RECIST v1.1
PFS is defined as the time from randomization to the first occurrence of radiographic disease progression determined by blinded independent central review (BIRC) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or death due to any cause within 12 weeks after last tumor assessment (to avoid censoring death as non-event if no progression documented). Patients alive and without progression at data cutoff are censored at the date of last adequate tumor assessment.
Measured: From randomization to the date of first documented radiographic disease progression or death from any cause, whichever occurs first, assessed up to approximately 24 months
Secondary outcomes (3)
Investigator-assessed Progression-Free Survival (PFS) per RECIST v1.1
PFS assessed by the local investigator using the same RECIST v1.1 criteria and scan schedule as the BIRC pathway, but without blinding to treatment assignment. Defined as time from randomization to first investigator-determined radiographic disease progression, or death from any cause (if no prior progression). No central adjudication. Used for sensitivity analysis against the primary BIRC-based PFS.
Measured: From randomization to first documented radiographic progression by investigator or death from any cause, whichever occurs first, assessed up to ~24 months
Overall Survival (OS)
OS is defined as the time from randomization to the date of death due to any cause. Patients alive at the time of data cutoff will be censored at the last known alive date. OS will be estimated using the Kaplan-Meier method and compared between arms by log-rank test; hazard ratio and 95% CI from Cox proportional hazards model reported.
Measured: From randomization to date of death from any cause, assessed up to approximately 36 months (or final analysis cut-off)
Incidence, severity, and relationship of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From first dose of study drug to 30 days after last dose (or 90 days for SAEs / death), assessed up to ~24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Advanced Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou JOYO Pharma Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816380
- Sponsor's protocol ID
- JYP0322M301
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of JYP0322 Versus Crizotinib in Previously Untreated ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07816380
- Acronym / sponsor ID
- JYP0322M301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Guangzhou JOYO Pharma Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label, multicenter phase III study to evaluate the efficacy and safety of JYP0322 compared with crizotinib in previously untreated ROS1-positive locally advanced or metastatic non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JYP0322 Tablets | Experimental | Drug: JYP0322 Tablets |
| Crizotinib Capsules | Active comparator | Drug: Crizotinib Capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Voluntary participation and signed written informed consent (ICF) before any study-specific procedure.
- Age ≥ 18 years at screening. Histologically or cytologically confirmed, unresectable locally advanced (AJCC 9th edition stage IIIB or IIIC not amenable to multimodality therapy) or metastatic (stage IV) ROS1-positive non-small cell lung cancer (NSCLC).
- ROS1 gene rearrangement/fusion positivity confirmed by a qualified local laboratory using PCR, NGS, or FISH. IHC alone is not acceptable. A written report of the ROS1 test must be provided.
- Sufficient and adequate archival tumor tissue must be available for central laboratory ROS1 retesting per the Central Lab Manual; if no archival tissue is available, a fresh tumor biopsy is required.
- No prior ROS1 TKI therapy. Prior systemic therapy limited to ≤1 line of standard chemotherapy:
Key exclusion criteria (15 listed)
- History of severe cardiovascular or cerebrovascular disease, including but not limited to: clinically significant cardiac rhythm or conduction abnormality (e.g., ventricular arrhythmia requiring intervention, 2nd-3rd degree AV block); acute coronary syndrome, congestive heart failure, aortic dissection, severe stable/unstable angina, coronary/peripheral vascular intervention, stroke or other ≥Grade 3 cerebrovascular event (including TIA), pulmonary embolism, DVT or other clinically significant thrombosis within 6 months before randomization; NYHA > Class II heart failure or LVEF < 50%; any uncontrolled atrial fibrillation; QTcF > 470 ms or symptomatic bradycardia < 45 bpm; known congenital long QT syndrome or history of QT prolongation.
- Active infection requiring IV antibiotics or hospitalization at randomization. Acute flare of dysphagia or GI disease affecting absorption (Crohn's, UC, short bowel syndrome, or other malabsorption).
- Failure to recover from prior antitumor therapy toxicity to baseline or ≤Grade 1 (CTCAE v5.0), except alopecia, Grade 2 peripheral neuropathy, or hypothyroidism controlled by replacement judged safe by investigator.
- Major surgical procedure (other than dx/biopsy/drainage) within 4 weeks before randomization, or anticipated major surgery during study; vascular access placement and minor procedures (catheter, core needle biopsy) allowed.
- Other primary malignancy except: adequately treated melanoma/skin carcinoma/cervical carcinoma in situ; treated non-metastatic prostate cancer; or other primary malignancy with no relapse ≥3 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JYP0322 TabletsOral administration, 150 mg each dose, three times daily (TID), continuous dosing. | Drug | JYP0322 Tablets |
| Crizotinib CapsulesOral administration, 250 mg twice daily (BID), continuous dosing. | Drug | Crizotinib Capsules |
Primary outcome
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR/BIRC) per RECIST v1.1
Time frame: From randomization to the date of first documented radiographic disease progression or death from any cause, whichever occurs first, assessed up to approximately 24 months
PFS is defined as the time from randomization to the first occurrence of radiographic disease progression determined by blinded independent central review (BIRC) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or death due to any cause within 12 weeks after last tumor assessment (to avoid censoring death as non-event if no progression documented). Patients alive and without progression at data cutoff are censored at the date of last adequate tumor assessment.
3 secondary outcomes
Investigator-assessed Progression-Free Survival (PFS) per RECIST v1.1
Time frame: From randomization to first documented radiographic progression by investigator or death from any cause, whichever occurs first, assessed up to ~24 months
Overall Survival (OS)
Time frame: From randomization to date of death from any cause, assessed up to approximately 36 months (or final analysis cut-off)
Incidence, severity, and relationship of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From first dose of study drug to 30 days after last dose (or 90 days for SAEs / death), assessed up to ~24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JYP0322 Tablets and Crizotinib Capsules in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Guangzhou JOYO Pharma Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR/BIRC) per RECIST v1.1 (time frame: From randomization to the date of first documented radiographic disease progression or death from any cause, whichever occurs first, assessed up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.