Study of Toripalimab for Limited-Stage Small Cell Lung Cancer Following Concurrent Chemoradiotherapy

NCT04418648 | Terminated Phase 2

• 1 other identifier: 2019-FXY-243
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The phase II, randomised study is to explore the efficacy and safety of toripalimab as consolidation therapy in patients with limited-stage small cell lung cancer who have not progressed following concurrent chemoradiation therapy

Conditions

Small Cell Lung Cancer Limited Stage

Keywords

Consolidation therapy; Toripalimab; Concurrent chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Time from the date of randomisation until death from any cause or first documented disease progression determined by RECISIT v1.1

  2 years

Secondary Outcomes (7)

• Overall Survival

  2 years

• Objective Response Rate

  2 years

• Duration of Response

  2 years

• Adverse Event

  2 years

• Quality of Life (EORTC QLQ-C30)

  2 years

Study Arms (2)

Toripalimab Consolidation

EXPERIMENTAL

Patients in experimental group will receive toripalimab consolidation (240 mg) via iv infusion Q3W.

Drug: Toripalimab

Observation

NO INTERVENTION

Patients in this group will receive observation.

Interventions

Toripalimab DRUG

Toripalimab consolidation (240 mg) via iv infusion once every 3 weeks. Administration of toripalimab will commence on Day 1 following randomisation to toripalimab after confirmation of eligibility and will continue on a Q3W schedule for a maximum duration of 6 months.

Toripalimab Consolidation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed, written and dated informed consent prior to any study specific procedures;
• Male or female aged 18-75 years;
• Histologically- or cytologically-documented SCLC;
• Stage I-III (AJCC/UICC 8th TNM Staging), with all lesions can be included in a tolerable radiotherapy field (limited-stage);
• Previous thoracic radiotherapy (45 Gy twice daily or 60-66 Gy once daily) and concurrent etoposide and platinum for four cycles; Dose coverage ≥ 85% of PTV-GTV. Radiotherapy started before the completion of the third cycle of chemotherapy;
• CR, PR or SD after concurrent chemoradiotherapy (RECIST v1.1);
• PCI is allowed and should be completed within 90 days after the completion of chemoradiotherapy;
• Randommization shoud be completed within 90 days after the completion of chemoradiotherapy;
• Life expectancy ≥12 weeks;
• World Health Organization (WHO) Performance Status of 0 or 1;
• Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients within 7 days before the use of study drug (HCG has a minimum sensitivity of 25 IU/L or equivalent);
• Women must be non-breastfeeding;
• Women of reproductive age (WOCBP) must agree to comply with the contraceptive method during the study toripalimab treatment and for a period of 3 months following the last administration of the study treatment (i.e., 30 days \[ovulation cycle\] plus approximately 5 half-lives of the study drug);
• Men who have sex with WOCBP must agree to comply with the contraceptive method during the study nivolumab treatment and for 5 months after the last administration of the study treatment (i.e. 90 days \[sperm renewal cycle\] plus approximately 5 half-lives of the study drug);
• Spermless men do not have to comply with contraceptive requirements. WOCBP who continues to be asexual with the opposite sex does not have to comply with contraceptive requirements, but must still undergo the pregnancy tests described in this section;

You may not qualify if:

• Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study;
• Mixed small cell and non-small cell lung cancer histology;
• Extensive-stage SCLC;
• Histologically-confirmed malignant pleural or pericardial effusion;
• Sequential chemoradiotherapy, or radiotherapy did not start before the completion of the third cycle of chemotherapy;
• Progressive disease after concurrent chemoradiotherapy (RECIST v1.1) and before randomization;
• Prior use of surgery, radiotherapy or chemotherapy for SCLC, with the exceptions of thoracic concurrent chemoradiotherapy and PCI;
• Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy will be excluded from randomization;
• Patients with Grade ≥2 pneumonitis from prior chemoradiation therapy will be excluded from randomization;
• Current or prior use of immunosuppressive medication within 28 days before the first dose of toripalimab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the previous chemoradiotherapy for SCLC is allowed;
• Prior exposure to any anti-programmed cell death protein(PD)-1 or anti-PD-L1 antibody;
• Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access);
• Active or prior documented autoimmune disease within the past 2 years including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granuloma, Sjogren's syndrome, Guillain Barre syndrome or multiple sclerosis;
• History of primary immunodeficiency;
• History of organ transplant that requires therapeutic immunosuppression;

Sponsors & Collaborators

• Sun Yat-sen University: lead
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Guangzhou Panyu Central Hospital: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, 510060, China

Location

MeSH Terms

Interventions

toripalimab

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: Prof.

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 5, 2020
• Study Start: June 1, 2020
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

CN (1)