NCT06969027Active, not recruitingPhase 2
JS207Combined With Chemotherapy in First-line Treatment of Advanced NSCLC
JS207 (PD-1/VEGF Dual Antibody) Combined With Chemotherapy in First-line Treatment of Advanced Non-small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
This study targets patients with in first-line treatment of advanced NSCLC, enrolling 60-84 participants. Patients will receive Arm 1: JS207 (10 mg/kg or 15 mg/kg, IV, D1) + Pemetrexed (500 mg/m2 IV, D1) + a platinum (carboplatin AUC 5, D1 or cisplatin 75 mg/m2, D1), Q3W, for 4 cycles followed by JS207 (10 mg/kg or 15 mg/kg, IV, D1) + pemetrexed (500 mg/m2 IV, D1), Q3W, until meeting the treatment withdrawal criteria. Arm 2: JS207 (10 mg/kg or 15 mg/kg, IV, D1) + Paclitaxel (175 mg/m2 IV, D1) + a platinum (carboplatin AUC 5, D1 or cisplatin 75 mg/m2, D1), Q3W, for 4 cycles followed by JS207 (10 mg/kg or 15 mg/kg, IV, D1), Q3W, until meeting the treatment withdrawal criteria.The study aims to assess the safety, tolerability, and preliminary efficacy of JS207 combination therapy.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 69 (actual)
- First submitted
- 28 Apr 2025
- Start date
- 19 Jun 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT06969027
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 69
- From 19 Jun 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 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
- Treatment received as listed in the protocol, including immunologically mediated treatment; drugs targeting the anti-VEGF pathway, etc.
- Gastrointestinal perforation, intra-abdominal fistula or intra-abdominal abscess occurred within 6 months before the first administration, or currently having high-risk factors for perforation/fistula formation of the hollow viscus as judged by the investigator.
- Expected that the toxicity of previous anti-tumor treatment has not recovered to ≤ grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE).
- Known allergy to the investigational drug or its excipients, pemetrexed, platinum drugs (carboplatin/cisplatin), or known history of ≥ grade 3 allergy to antibody drugs
Other illness
- Histopathologically or cytopathologically confirmed to have combined neuroendocrine (including small cell lung cancer and large cell neuroendocrine carcinoma) components.
- Having an obvious bleeding tendency or a history of severe coagulation dysfunction.
- Having a serious, unhealed or ruptured wound, active ulcer or untreated fracture.
- Having uncontrolled hypertension, or a history of hypertensive crisis or hypertensive encephalopathy.
Who the study is looking for
- Age between 18 and 75 years old (both 18 and 75 years old included) at the time of signing the informed consent form, applicable to both males and females.
- Locally advanced (stage IIIB/IIIC), metastatic or recurrent non-small cell lung cancer (NSCLC) confirmed by histology or cytology, which is not eligible for radical surgery or radical chemoradiotherapy.
- History of no systemic antitumor therapy for Metastatic or recurrent NSCLC; for subjects who have received adjuvant/neoadjuvant/consolidation therapy (Chemotherapy, radiotherapy, or other therapy), they can be enrolled if the interval between the last treatment and recurrence is more than 6 months.
- Tissue samples are required for PD-L1 test. New tissue samples are preferred. If new tissue samples are not available, archived samples can be provided.
- According to the RECIST v1.1 criteria, the subject has at least 1 measurable lesion.
- Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
- Expected survival period ≥ 12 weeks.
- The function of important organs meets the requirements of the protocol.
- Female subjects of childbearing potential, and male subjects whose partners are females of childbearing age, need to adopt a highly effective contraceptive measure during the study treatment period and for at least 6 months after the last administration.
- Voluntarily joining this study, signing the informed consent form, having good compliance, and cooperating with the follow-up.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shandong First Medical University Affiliated Neoplasm Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.