Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer

Phase 2

Not yet recruiting

• Conditions: Small Cell Lung Cancer Extensive Stage; Small Cell Lung Cancer Recurrent
• Interventions: Drug: Toripalimab; Drug: JS004; Drug: Etoposide; Drug: Platinum

• Registration Number: NCT06648200
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary

For extensive-stage small cell lung cancer (SCLC), platinum-chemotherapy (cisplatin or carboplatin) combined with etoposide as the first-line treatment is recommended. However, the recurrence rate is extremely high after the initial first-line treatment. For those who relapse or progress within more than six minths after the end of the-first-line treatment, ...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-16
• Last Update Submitted: 2024-10-16
• Study First Posted: 2024-10-18
• Last Update Posted: 2024-10-18
• Study Start: 2024-11-01
• Primary Completion: 2030-09-01
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 or EBUS, and extensive stage or recurrent confirmed by imageological examinations or relapsed within more than six months after radical treatment SCLC;
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. Fertile female patients must voluntarily use effective contraceptives from the start of the trial to within 30 days after its completion, and urine or serum pregnancy test results within 7 days prior to enrollment are negative;
9. Unsterilized male patients must voluntarily use effective contraception during the trial period and for 30 days after its conclusion.

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Exclusion Criteria

1. Patients with a malignancy other than SCLC within five years prior to the start of this trial;
2. Participants with any unstable systemic disease (including uncontrolled hypertension, severe arrhythmia, etc.);
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 active hepatitis B, hepatitis C or HIV;
6. Participants with Interstitial lung disease currently;
7. Pregnant or lactating women;
8. Any malabsorption;
9. Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
10. Other factors that researchers think it is not suitable for enrollment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapy With Toripalimab Combined With Platinum-based Doublet Chemotherapy	Toripalimab	In this arm, 50 patients with extensive-stage small cell lung cancer or relapsed within more than 6 months after SCLC radical treatment will receive 4 circles of toripalimab combined with platinum-based doublet chemotherapy. Then patients received maintenance treatment with toripalimab until the disease progressed.
Therapy With Toripalimab Combined With Platinum-based Doublet Chemotherapy	Etoposide	In this arm, 50 patients with extensive-stage small cell lung cancer or relapsed within more than 6 months after SCLC radical treatment will receive 4 circles of toripalimab combined with platinum-based doublet chemotherapy. Then patients received maintenance treatment with toripalimab until the disease progressed.
Therapy With Toripalimab Combined With Platinum-based Doublet Chemotherapy	Platinum	In this arm, 50 patients with extensive-stage small cell lung cancer or relapsed within more than 6 months after SCLC radical treatment will receive 4 circles of toripalimab combined with platinum-based doublet chemotherapy. Then patients received maintenance treatment with toripalimab until the disease progressed.
Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy	JS004	In this arm, 50 patients with extensive-stage small cell lung cancer or relapsed within more than 6 months after SCLC radical treatment will receive 4 circles of toripalimab and JS004 combined with platinum-based doublet chemotherapy. Then patients received maintenance treatment with toripalimab and JS004 until the disease progressed.
Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy	Toripalimab	In this arm, 50 patients with extensive-stage small cell lung cancer or relapsed within more than 6 months after SCLC radical treatment will receive 4 circles of toripalimab and JS004 combined with platinum-based doublet chemotherapy. Then patients received maintenance treatment with toripalimab and JS004 until the disease progressed.
Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy	Etoposide	In this arm, 50 patients with extensive-stage small cell lung cancer or relapsed within more than 6 months after SCLC radical treatment will receive 4 circles of toripalimab and JS004 combined with platinum-based doublet chemotherapy. Then patients received maintenance treatment with toripalimab and JS004 until the disease progressed.
Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy	Platinum	In this arm, 50 patients with extensive-stage small cell lung cancer or relapsed within more than 6 months after SCLC radical treatment will receive 4 circles of toripalimab and JS004 combined with platinum-based doublet chemotherapy. Then patients received maintenance treatment with toripalimab and JS004 until the disease progressed.

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	up to 60 months	It is defined as the time (months) from the first administration of drug in this study to the disease progression or death (including any cause of death in the case of no progression) as recorded in CRF, regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	up to 30 months	ORR is defined according to the RECIST v1.1 criteria.
Treatment-related adverse event (TRAE)	Up to 30 months	TRAE is defined and classified according to NCI-CTCAE v5.0 in all participants.
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.
Health related quality of life (HRQol)：EORTC-QLQ-C30	up 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 43 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.
Health related quality of life (HRQol)：LC13	up to 5 months	The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (LC13, Version 3).The items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively. The higher score, the worse quality.

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, China