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Trial Title:
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
Condition:
Stage III Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Carboplatin
Pemetrexed
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Specified dose on specified days.
Arm group label:
Control arm
Arm group label:
JS004 arm
Arm group label:
Safety run-in arm
Intervention type:
Drug
Intervention name:
JS004
Description:
Specified dose on specified days.
Arm group label:
JS004 arm
Arm group label:
Safety run-in arm
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Specified dose on specified days.
Arm group label:
Control arm
Arm group label:
JS004 arm
Arm group label:
Safety run-in arm
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Specified dose on specified days.
Arm group label:
Control arm
Arm group label:
JS004 arm
Arm group label:
Safety run-in arm
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Specified dose on specified days.
Arm group label:
Control arm
Arm group label:
JS004 arm
Arm group label:
Safety run-in arm
Intervention type:
Procedure
Intervention name:
Surgery
Description:
Patients with resectable tumor after neoadjuvant therapy will be treated with surgery.
Arm group label:
Control arm
Arm group label:
JS004 arm
Arm group label:
Safety run-in arm
Summary:
For stage III non-small cell lung cancer (NSCLC), neoadjuvant chemotherapy plus PD-1
antibody is recommended. However, most patients could not achieve complete pathological
response (CPR). New immunotherapeutic strategy is needed to achieve higher CPR rate.
JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA) which restrains
the function of immune cells and leads to immune escape of tumor cells. The combination
of PD-1 antibody and BTLA antibody has shown good therapeutic effect in solid tumors.
This trial aims to investigate the efficacy and safety of the therapeutic regimen of
toripalimab and JS004 plus chemotherapy in stage III NSCLC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The patient shall sign the Informed Consent Form.
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:
1. Participants who have received any systemic anti-cancer treatment for thymic
epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug
treatment, targeted drug treatment and experimental treatment;
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
July 1, 2023
Completion date:
July 1, 2030
Lead sponsor:
Agency:
Shanghai Pulmonary Hospital, Shanghai, China
Agency class:
Other
Source:
Shanghai Pulmonary Hospital, Shanghai, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05891080
