Non-small Cell Lung CancerPhase 2NCT06388031
ICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI
A Phase 2 study testing Immune checkpoint inhibitor in people with Non-small Cell Lung Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
An exploratory phase II trial of immune checkpoint inhibitors (ICIs, anti-PD-1/anti-PD-L1) as second-line treatment with advanced non-small cell lung cancer (NSCLC) who had long-term response to first-line immunotherapy (with or without chemotherapy). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Immune checkpoint inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 9 Aug 2024to 10 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have a thorough understanding of this study and voluntarily sign an informed consent form (ICF);
- Age between 18 and 80 years, any gender;
- Histologically or cytologically confirmed stage III-IV non-small cell lung cancer (NSCLC);
- Previous treated with first-line immunotherapy (immunotherapeutic agents include currently marketed anti-PD-L1 or anti-PD-1 monoclonal antibodies: pembrolizumab, nivolumab, atezolizumab, durvalumab, tislelizumab, toripalimab, sintilimab, camrelizumab, etc.; investigational drugs not yet marketed need discussion with the study team prior to enrollment; with or without platinum-based doublet chemotherapy) for at least 35 cycles or disease stability confirmed by imaging assessment for at least 2 years, and disease progression;
- Measurable disease (at least 1 lesion) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
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- Adequate organ function:
- Hematology: Absolute neutrophil count (ANC) ≥1500/μL; Platelets ≥100000/μL; Hemoglobin ≥9.0g/dL; Renal: Serum creatinine ≤1.5×ULN or calculated creatinine clearance (CrCl) ≥60 mL/min (using Cock-Gault formula); Hepatic: Total bilirubin ≤1.5 ×ULN or, for subjects with total bilirubin levels >1.5×ULN, direct bilirubin within normal limits; AST (SGOT) and ALT (SGPT) ≤2.5×ULN; Coagulation: International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (APTT) ≤1.5×ULN;
- Subjects must be willing and able to comply with study visits, treatment plans, laboratory tests, and other study procedures;
- Female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use highly effective contraception during the study and for 180 days after the last dose of the study drug.
Who cannot join
- Received two or more prior systemic therapies;
- Known sensitive EGFR mutation (EGFR exon19 del or EGFR exon21 L858R) or ALK rearrangement;
- Symptomatic or progressing CNS metastases, leptomeningeal metastases;
- History of autoimmune disease, active autoimmune disease, immunodeficiency, or requiring systemic corticosteroid/immunosuppressive therapy; (except: a history of hypothyroidism; well-controlled stable type I diabetes mellitus);
- Idiopathic pulmonary fibrosis (including interstitial pneumonia), drug-induced pneumonitis, history of (non-infectious) pneumonia/interstitial lung disease requiring steroid therapy;
- Known active tuberculosis, human immunodeficiency virus (HIV) infection; active hepatitis B (defined as positive HBsAg or positive hepatitis B virus DNA test result above the detection limit) or hepatitis C (defined as known positive HCV antibody result, known quantitative HCV-RNA analysis result above the detection limit) history; other known active infections requiring systemic therapy;
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- Received systemic immunostimulatory therapy within 4 weeks before initiation of study treatment or within 5 half-lives of the drug (whichever is longer);
- Pregnancy, lactation, planning to become pregnant, or fathering a child during the anticipated duration of the study (from screening visit to 180 days after the last dose of investigational drug);
- Prior allogeneic tissue/organ transplantation and other conditions unsuitable for immunotherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Minjiang Chen, MD., +8618618340880, minjiangchen@163.com
About this study
Official title: A Multicenter, Single-Arm Pilot Study of Immune Checkpoint Inhibitors in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer Who Had Long-Term (Two Years or Longer) Response to First-Line Immunotherapy
An exploratory phase II trial of immune checkpoint inhibitors (ICIs, anti-PD-1/anti-PD-L1) as second-line treatment with advanced non-small cell lung cancer (NSCLC) who had long-term response to first-line immunotherapy (with or without chemotherapy).
This study aims to evaluate efficacy and safety of ICI rechallenge in long-term responders to prior ICI. Furthermore, it seeks to identify biomarkers capable of predicting the efficacy of immunotherapy and prognosis.
Read the detailed description
This is a multi-center study. The study plans to include a total of 27 advanced NSCLCs who had benefited from first-line immunotherapy over two years before disease progression.
Participants will receive up to 17 cycles of ICI (anti-PD-1 or anti-PD-L1) monotherapy.
Optional ICI monotherapy regimens include: Pembrolizumab 200mg every 3 weeks, or Tislelizumab 200mg every 3 weeks, or Camrelizumab 200mg every 3 weeks, or Toripalimab 240mg every 3 weeks.
The outcomes including efficacy and safety will be examined. Additionally, peripheral blood samples will be collected before treatment, and at the 6th, 12th, and 24th weeks after treatment initiation to explore biomarkers for immunotherapy. Also it is highly recommended to collect pretreatment tumor tissue from patients.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Immune checkpoint inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune checkpoint inhibitorDrug
Also called Keytruda
Physician's choice immunotherapy with one of the following every 21 days until disease progression or intolerable toxicity or up to 17 cycles:
- Pembrolizumab 200mg;
- Tislelizumab 200mg;
- Camrelizumab 200mg;
- Toripalimab 240mg.
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy | Experimental | Immune checkpoint inhibitor (anti-PD/1 or anti-PD-L1) monotherapy Receives: Drug: Immune checkpoint inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Time from the date of treatment start to date of disease progression met by RECIST 1.1 or death from any cause.
Measured: 5 months
Secondary outcomes (3)
Overall Survival (OS)
Time from the date of treatment start to date of death from any cause.
Measured: 24 months
Objective Response Rate (ORR)
Proportion of patients with complete and partial responses to immunotherapy according to RECIST 1.1.
Measured: 5 months
Progression Free Survival 2 (PFS 2)
Time from the date of treatment start to the date of disease progression or death after initiation of subsequent anti-tumor therapy.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start9 Aug 2024
- Primary completion10 Jan 2027 (estimated)
- Study completion10 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minjiang Chen, Peking Union Medical College Hospital
- Investigators
- Minjiang Chen, MD., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388031
- Sponsor's protocol ID
- CAPTRAL2024v1
- Status last verified
- Nov 2024
- First submitted
- 24 Apr 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The result of the study and all the supporting informations will be shared in the form of publishing article.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Arm Pilot Study of Immune Checkpoint Inhibitors in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer Who Had Long-Term (Two Years or Longer) Response to First-Line Immunotherapy
- ClinicalTrials.gov ID
- NCT06388031
- Acronym / sponsor ID
- CAPTRAL2024v1
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 10 Dec 2027 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An exploratory phase II trial of immune checkpoint inhibitors (ICIs, anti-PD-1/anti-PD-L1) as second-line treatment with advanced non-small cell lung cancer (NSCLC) who had long-term response to first-line immunotherapy (with or without chemotherapy).
This study aims to evaluate efficacy and safety of ICI rechallenge in long-term responders to prior ICI. Furthermore, it seeks to identify biomarkers capable of predicting the efficacy of immunotherapy and prognosis.
Detailed description
This is a multi-center study. The study plans to include a total of 27 advanced NSCLCs who had benefited from first-line immunotherapy over two years before disease progression.
Participants will receive up to 17 cycles of ICI (anti-PD-1 or anti-PD-L1) monotherapy.
Optional ICI monotherapy regimens include: Pembrolizumab 200mg every 3 weeks, or Tislelizumab 200mg every 3 weeks, or Camrelizumab 200mg every 3 weeks, or Toripalimab 240mg every 3 weeks.
The outcomes including efficacy and safety will be examined. Additionally, peripheral blood samples will be collected before treatment, and at the 6th, 12th, and 24th weeks after treatment initiation to explore biomarkers for immunotherapy. Also it is highly recommended to collect pretreatment tumor tissue from patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy | Experimental | Drug: Immune checkpoint inhibitorImmune checkpoint inhibitor (anti-PD/1 or anti-PD-L1) monotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants must have a thorough understanding of this study and voluntarily sign an informed consent form (ICF);
- Age between 18 and 80 years, any gender;
- Histologically or cytologically confirmed stage III-IV non-small cell lung cancer (NSCLC);
- Previous treated with first-line immunotherapy (immunotherapeutic agents include currently marketed anti-PD-L1 or anti-PD-1 monoclonal antibodies: pembrolizumab, nivolumab, atezolizumab, durvalumab, tislelizumab, toripalimab, sintilimab, camrelizumab, etc.; investigational drugs not yet marketed need discussion with the study team prior to enrollment; with or without platinum-based doublet chemotherapy) for at least 35 cycles or disease stability confirmed by imaging assessment for at least 2 years, and disease progression;
- Measurable disease (at least 1 lesion) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
Key exclusion criteria (9 listed)
- Received two or more prior systemic therapies;
- Known sensitive EGFR mutation (EGFR exon19 del or EGFR exon21 L858R) or ALK rearrangement;
- Symptomatic or progressing CNS metastases, leptomeningeal metastases;
- History of autoimmune disease, active autoimmune disease, immunodeficiency, or requiring systemic corticosteroid/immunosuppressive therapy; (except: a history of hypothyroidism; well-controlled stable type I diabetes mellitus);
- Idiopathic pulmonary fibrosis (including interstitial pneumonia), drug-induced pneumonitis, history of (non-infectious) pneumonia/interstitial lung disease requiring steroid therapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune checkpoint inhibitorAlso: KeytrudaPhysician's choice immunotherapy with one of the following every 21 days until disease progression or intolerable toxicity or up to 17 cycles: * Pembrolizumab 200mg; * Tislelizumab 200mg; * Camrelizumab 200mg; * Toripalimab 240mg. | Drug | Immunotherapy |
Primary outcome
Progression Free Survival (PFS)
Time frame: 5 months
Time from the date of treatment start to date of disease progression met by RECIST 1.1 or death from any cause.
3 secondary outcomes
Overall Survival (OS)
Time frame: 24 months
Objective Response Rate (ORR)
Time frame: 5 months
Progression Free Survival 2 (PFS 2)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No. The result of the study and all the supporting informations will be shared in the form of publishing article.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Minjiang Chen, MD. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immune checkpoint inhibitor in people with Non-small Cell Lung Cancer, run by Peking Union Medical College Hospital 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 10 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 7 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minjiang Chen, MD. (+8618618340880, minjiangchen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.