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

NCT06648200 | Not Yet Recruiting Phase 2

• 1 other identifier: LungMate-031
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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, chose the current guideline recommendation trearment plan has the poor prognosis. A new immunotherapeutic strategy is needed to achieve better anti-tumor effects. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA), which restrains immune cells; function and leads to immune escape of tumor cells. The combination of PD-1 and BTLA antibodies has shown a good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 combined with platinum-based doublet chemotherapy in extensive-stage SCLC or relapsed within more than six months after radical treatment SCLC.

Conditions

Small Cell Lung Cancer Extensive Stage; Small Cell Lung Cancer Recurrent

Keywords

small cell lung cancer; Toripalimab; JS004; Extensive-stage; Recurrent

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  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.

  up to 60 months

Secondary Outcomes (5)

• Objective response rate (ORR)

  up to 30 months

• Treatment-related adverse event (TRAE)

  Up to 30 months

• Overall survival (OS)

  up to 60 months

• Health related quality of life (HRQol)：EORTC-QLQ-C30

  up to 5 months

• Health related quality of life (HRQol)：LC13

  up to 5 months

Study Arms (2)

Therapy With Toripalimab Combined With Platinum-based Doublet Chemotherapy

ACTIVE COMPARATOR

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.

Drug: Toripalimab; Drug: Etoposide; Drug: Platinum

Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy

EXPERIMENTAL

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.

Drug: JS004; Drug: Toripalimab; Drug: Etoposide; Drug: Platinum

Interventions

JS004 DRUG

Specified dose on specified days.

Also known as: tifcemalimab

Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy

Toripalimab DRUG

Specified dose on specified days.

Therapy With Toripalimab Combined With Platinum-based Doublet Chemotherapy; Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy

Etoposide DRUG

Specified dose on specified days.

Therapy With Toripalimab Combined With Platinum-based Doublet Chemotherapy; Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy

Platinum DRUG

Specified dose on specified days.

Therapy With Toripalimab Combined With Platinum-based Doublet Chemotherapy; Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient shall sign the Informed Consent Form;
• Aged 18 ≥ years;
• 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;
• Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1;
• Life expectancy is at least 12 weeks;
• At least 1 measurable lesion according to RECIST 1.1;
• Patients with good function of other main organs (liver, kidney, blood system, etc.);
• 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;
• Unsterilized male patients must voluntarily use effective contraception during the trial period and for 30 days after its conclusion.

You may not qualify if:

• Patients with a malignancy other than SCLC within five years prior to the start of this trial;
• Participants with any unstable systemic disease (including uncontrolled hypertension, severe arrhythmia, etc.);
• With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
• Participants who are allergic to the test drug or any auxiliary materials;
• Participants with active hepatitis B, hepatitis C or HIV;
• Participants with Interstitial lung disease currently;
• Pregnant or lactating women;
• Any malabsorption;
• Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
• Other factors that researchers think it is not suitable for enrollment.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Recurrence

Interventions

toripalimab; Etoposide; Platinum

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

Peng Zhang, PhD

CONTACT

02165115006; zhangpeng1121@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All enrolled patients were randomly assigned to one of two groups. Patients in group 1 received toripalimab combined with etoposide and platinum Chemotherapy; patients in group 2 received toripalimab and JS004 combined with etoposide and platinum Chemotherapy.

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 18, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

CN (1)