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NCT Number: NCT06648200

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

JS004

Drug

Specified dose on specified days.

Other names: tifcemalimab

Toripalimab

Drug

Specified dose on specified days.

etoposide

Drug

Specified dose on specified days.

Platinum

Drug

Specified dose on specified days.

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: 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 outcomes

  1. Objective response rate (ORR)

    Time frame: up to 30 months

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

  2. Treatment-related adverse event (TRAE)

    Time frame: Up to 30 months

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

  3. Overall survival (OS)

    Time frame: 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.

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

    Time frame: 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.

  5. Health related quality of life (HRQol):LC13

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Peng Zhang, PhD

CONTACT

[email protected]

02165115006

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study title

Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer: a Single-center, Randomized Trial

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Oct 18, 2024
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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