Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy for Limited-stage Small Cell Lung Cancer : A Phase 2 Trial

Registration Number
NCT06256237
Lead Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Brief Summary

For limited-stage small cell lung cancer (SCLC), neoadjuvant chemotherapy plus PD-1 antibody is recommended. However, most patients cannot achieve a complete pathological response (CPR). A new immunotherapeutic strategy is needed to achieve a higher CPR rate. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA), which restrains immune cells...

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
30
Inclusion Criteria
  1. The patient shall sign the Informed Consent Form.
  2. Aged 18 ≥ years.
  3. Histological or cytological diagnosis of SCLC by needle biopsy, and limited stage 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. Without systematic metastasis (including M1a, M1b and M1c);
  9. Expected to be completely resected
  10. Patients with lung function can tolerate surgery
  11. 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.
  12. 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).
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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. Patients with a malignancy other than SCLC within five years prior to the start of this trial;
  3. 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;
  4. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
  5. Participants who are allergic to the test drug or any auxiliary materials;
  6. Participants with Interstitial lung disease currently;
  7. Participants with active hepatitis B, hepatitis C or HIV;
  8. Pregnant or lactating women;
  9. Any malabsorption;
  10. Participants suffering from nervous system diseases or mental diseases that cannot cooperate
  11. Other factors that researchers think it is not suitable for enrollment.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum ChemotherapyJS004In this arm, 30 patients with limited-stage small cell lung cancer will receive 4 circles of neoadjuvant toripalimab and JS004 combined with etoposide and platinum chemotherapy. And those resectable after neoadjuvant therapy will be treated with surgery. Postoperative patients receive two cycles of toripalimab and JS004 combined with etoposide and platinum chemotherapy. then patients received maintenance treatment with toripalimab and JS004 until the disease progressed.
Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum ChemotherapysurgeryIn this arm, 30 patients with limited-stage small cell lung cancer will receive 4 circles of neoadjuvant toripalimab and JS004 combined with etoposide and platinum chemotherapy. And those resectable after neoadjuvant therapy will be treated with surgery. Postoperative patients receive two cycles of toripalimab and JS004 combined with etoposide and platinum chemotherapy. then patients received maintenance treatment with toripalimab and JS004 until the disease progressed.
Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum ChemotherapyPlatinumIn this arm, 30 patients with limited-stage small cell lung cancer will receive 4 circles of neoadjuvant toripalimab and JS004 combined with etoposide and platinum chemotherapy. And those resectable after neoadjuvant therapy will be treated with surgery. Postoperative patients receive two cycles of toripalimab and JS004 combined with etoposide and platinum chemotherapy. then patients received maintenance treatment with toripalimab and JS004 until the disease progressed.
Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum ChemotherapyToripalimabIn this arm, 30 patients with limited-stage small cell lung cancer will receive 4 circles of neoadjuvant toripalimab and JS004 combined with etoposide and platinum chemotherapy. And those resectable after neoadjuvant therapy will be treated with surgery. Postoperative patients receive two cycles of toripalimab and JS004 combined with etoposide and platinum chemotherapy. then patients received maintenance treatment with toripalimab and JS004 until the disease progressed.
Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum ChemotherapyEtoposideIn this arm, 30 patients with limited-stage small cell lung cancer will receive 4 circles of neoadjuvant toripalimab and JS004 combined with etoposide and platinum chemotherapy. And those resectable after neoadjuvant therapy will be treated with surgery. Postoperative patients receive two cycles of toripalimab and JS004 combined with etoposide and platinum chemotherapy. then patients received maintenance treatment with toripalimab and JS004 until the disease progressed.
Primary Outcome Measures
NameTimeMethod
Pathologic complete response (PCR) rateUp to 30 months

PCR rate is defined as the proportion of participants who have achieved pathologic complete response (on routine hematoxylin and eosin staining, no tumor cell can be found in tumor bed or lymph node) in all participants.

Secondary Outcome Measures
NameTimeMethod
Major pathologic response (MPR) rateUp to 30 months

MPR rate is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants.

Objective response rate (ORR)up to 30 months

ORR is defined according to the RECIST v1.1 criteria.

Event-free survival (EFS)up to 60 months

Event-free survival (EFS) is defined as the length of time (months) from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason o...

Overall survival (OS)up to 60 months

It is defined as the time (months) from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.

Treatment-related adverse event (TRAE)Up to 30 months

TRAE is defined and classified according to NCI-CTCAE v5.0 in all participants.

EORTC-QLQ-C30 scaleup to 5 months

The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30, Version 3). EORTC's QLQ-C30 (V3.0) is a core scale for lung cancer patients, with a total of 30 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options. The other items are divid...

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital

🇨🇳

Shanghai, China

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