Neoadjuvant Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy for Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer: A Randomised Controlled, Open-label, Phase 2 Trial
NCT ID: NCT05891080
Last Updated: 2023-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
124 participants
INTERVENTIONAL
2023-07-01
2030-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Safety run-in arm
In this arm, 6 patients with resectable or potentially resectable stage III non-small cell lung cancer will receive 4 circles of neoadjuvant toripalimab and JS004 combined with platinum-based doublet chemotherapy and those resectable after neoadjuvant therapy will be treated with surgery.
Toripalimab
Specified dose on specified days.
JS004
Specified dose on specified days.
Pemetrexed
Specified dose on specified days.
Nab-paclitaxel
Specified dose on specified days.
Carboplatin
Specified dose on specified days.
Surgery
Patients with resectable tumor after neoadjuvant therapy will be treated with surgery.
JS004 arm
Patients with resectable or potentially resectable stage III non-small cell lung cancer will be randomized into this arm (59 patients) and receive 4 circles of neoadjuvant toripalimab and JS004 combined with platinum-based doublet chemotherapy and those resectable after neoadjuvant therapy will be treated with surgery.
Toripalimab
Specified dose on specified days.
JS004
Specified dose on specified days.
Pemetrexed
Specified dose on specified days.
Nab-paclitaxel
Specified dose on specified days.
Carboplatin
Specified dose on specified days.
Surgery
Patients with resectable tumor after neoadjuvant therapy will be treated with surgery.
Control arm
Patients with resectable or potentially resectable stage III non-small cell lung cancer will be randomized into this arm (59 patients) and receive 4 circles of neoadjuvant toripalimab combined with platinum-based doublet chemotherapy and those resectable after neoadjuvant therapy will be treated with surgery.
Toripalimab
Specified dose on specified days.
Pemetrexed
Specified dose on specified days.
Nab-paclitaxel
Specified dose on specified days.
Carboplatin
Specified dose on specified days.
Surgery
Patients with resectable tumor after neoadjuvant therapy will be treated with surgery.
Interventions
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Toripalimab
Specified dose on specified days.
JS004
Specified dose on specified days.
Pemetrexed
Specified dose on specified days.
Nab-paclitaxel
Specified dose on specified days.
Carboplatin
Specified dose on specified days.
Surgery
Patients with resectable tumor after neoadjuvant therapy will be treated with surgery.
Eligibility Criteria
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Inclusion Criteria
2. Aged 18 ≥ years.
3. Histological or cytological diagnosis of NSCLC by needle biopsy, and stage IIIB-IIIC confirmed by imageological examinations (CT, PET-CT or EBUS).
4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
5. Life expectancy is at least 12 weeks.
6. At least 1 measurable lesion according to RECIST 1.1.
7. Patients with good function of other main organs (liver, kidney, blood system, etc.)
8. Patients with lung function can tolerate surgery;
9. Without systematic metastasis (including M1a, M1b and M1c);
10. Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
11. Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later).
Exclusion Criteria
2. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
4. Participants who are allergic to the test drug or any auxiliary materials;
5. Participants with Interstitial lung disease currently;
6. Participants with active hepatitis B, hepatitis C or HIV;
7. Pregnant or lactating women;
8. Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
9. Participated in another therapeutic clinical study;
10. Other factors that researchers think it is not suitable for enrollment.
18 Years
ALL
No
Sponsors
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Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Responsible Party
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Peng Zhang
Professor
Principal Investigators
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Peng Zhang, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Pulmonary Hospital, Shanghai, China
Central Contacts
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Other Identifiers
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LungMate-014
Identifier Type: -
Identifier Source: org_study_id
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