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Small Cell Lung Cancer Limited StagePhase 2NCT04418648

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

A Phase 2 study testing Toripalimab in people with Small Cell Lung Cancer Limited Stage, run by Sun Yat-sen University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Small Cell Lung Cancer Limited Stage
What is being tested?
Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
1 siteChina
Study dates
1 Jun 2020to 31 May 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
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  • 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;
  • Adequate organ and marrow function as defined below:
  • Forced expiratory volume in 1 second (FEV1) ≥ 800ml;
  • Absolute neutrophil count ≥1.5 x 10^9/L (1500 per mm3);
  • Platelets ≥100 x 10^9/L (100,000 per mm3);
  • Haemoglobin ≥ 9.0 g/dL (5.59 mmol/L);
  • Serum creatinine clearance (CL) ≥ 50 mL/min by the Cockcroft-Gault formula (Cockcroft and -Gault 1976);
  • Serum bilirubin ≤1.5 x upper limit of normal (ULN);
  • Aspartate Transaminase (AST) and Alanine Transaminase (ALT) ≤ 2.5 x ULN.

Who cannot join

  • 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;
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  • 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;
  • Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Bazett's Correction;
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, hepatitis C , human immunodeficiency virus (HIV), or patients with positive HBsAg and HBV-DNA > 500 IU/ml, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent;
  • Known history of tuberculosis;
  • Receipt of live attenuated vaccination within 30 days prior to study entry;
  • History of another primary malignancy within 5 years prior to study entry, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ, breast intraductal carcinoma in situ or localized prostate cancer;
  • Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control;
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of the toripalimab or interpretation of patient safety or study results;
  • Any condition that, in the opinion of the investigator, not suitable for study entry.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, 510060

Other trials in China

About this study

Official title: A Phase II, Randomised Study of Toripalimab as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiotherapy

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

Being tested
Toripalimab
Keywords
Consolidation therapy, Toripalimab, Concurrent chemoradiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ToripalimabDrug

    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.

Study groups in NCT04418648
Study groupRoleWhat they receive
Toripalimab ConsolidationExperimentalPatients in experimental group will receive toripalimab consolidation (240 mg) via iv infusion Q3W.
Receives: Drug: Toripalimab
ObservationNo interventionPatients in this group will receive observation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (7)

  1. Overall Survival

    Time from the date of randomisation until death from any cause

    Measured: 2 years

  2. Objective Response Rate

    Best overall response (CR or PR) rate determined by RECISIT v1.1 across all assessment time-points during the period from randomisation to termination of protocol specific treatment

    Measured: 2 years

  3. Duration of Response

    Time from the date of first documented response of CR or PR until first documented progression or death, determined by RECISIT v1.1

    Measured: 2 years

  4. Adverse Event

    Number of participants with treatment-related adverse events determined by CTCAE v4.0

    Measured: 2 years

  5. Quality of Life (EORTC QLQ-C30)

    Quality of life score assessed by Quality of Life Questionnaire-Core 30 proposed by The European O-rganization for Reasearch and Treatment of Cancer. EORTC QLQ-C30 contained 30 items. Items 29 and 30 are rated on a scale of 1 to 7. The other items are divided into four grades: totally not, a little bit, a lot and very much, and scored on a scale of 1 to 4. For functional and overall health domain, a higher score refers to a better life quality; for symptom domain, a higher score refers to a worse life quality.

    Measured: 2 years

  6. Quality of Life (EORTC QLQ-LC13)

    Quality of life score assessed by Quality of Life Questionnare-Lung Cancer 13 proposed by The European O-rganization for Reasearch and Treatment of Cancer. EORTC QLQ-LC13 contained 13 items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Each item is scored on a scale 0 to 100, where 0 indicates no symptoms and 100 indicates the worst possible symptoms.

    Measured: 2 years

  7. ECOG performance status

    Performance status score assessed by Zubrod-ECOG-WHO method, range 0-5. A higher score refers to a worse quality of life.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2020
  2. Study start1 Jun 2020
  3. Primary completion31 May 2024
  4. Study completion31 May 2024

Why it stopped: Since the interim results of the ADRIATIC trial presented at the ASCO Annual Meeting in June 2024, the design of the control group is no longer consistent with current clinical practice.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04418648
Sponsor's protocol ID
2019-FXY-243
Status last verified
Feb 2026
First submitted
25 May 2020
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab in people with Small Cell Lung Cancer Limited Stage, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Since the interim results of the ADRIATIC trial presented at the ASCO Annual Meeting in June 2024, the design of the control group is no longer consistent with current clinical practice.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04418648.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.

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