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Efficacy and SafetyPhase 2NAJSCRNCT03623776

Neoadjuvant JS001, or JS001 in Combination With Pemetrexed and Carboplatin in Resectable NSCLC.

A Phase 2 study testing JS001, Pemetrexed and Carboplatin in people with Efficacy and Safety, run by Sun Yat-sen University at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

JS001 (Toripalimab) is a recombinant humanized anti-PD-1 monoclonal antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2. The purpose of this study is to studying neoadjuvant JS001, or JS001 in combination with pemetrexed and carboplatin to see how well it works in… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Efficacy and Safety
What is being tested?
JS001, Pemetrexed and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
1 Feb 2019to 1 Dec 2026
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

  • Target population is high risk NSCLC with resection option for potential cure, as assessed by a faculty surgeon at SYSUCC. This may include clinical stage IB (≥4cm), II and IIIA. Subjects with N3 nodal involvement are not included.
  • Subjects should not have a previously detected sensitizing EGFR mutation or ALK fusion oncogene.
  • Written informed consent provided.
  • Male and female patients aged ≥18 years, < 75 years.
  • Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
  • Blood and specimens before and after treatment must be provided
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Life expectancy ≥12 weeks.
  • Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
  • Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
  • Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
  • Female subjects should not be pregnant or breast-feeding.

Who cannot join

  • Known severe hypersensitivity to JS001 or any of the excipients of this product.
  • Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody (including any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • Prior chemotherapy or radiotherapy.
  • Subjects with active, known or suspected autoimmune disease. Subjects in conditions not expected to recur in the absence of an external trigger, or not requiring systemic treatment are permitted to enroll.
  • Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • Inability to comply with protocol or study procedures.
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  • A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
  • A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
  • History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
  • Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
  • Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over)
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Known history of active Hepatitis B or C.
  • Women who are pregnant or nursing.
  • Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Multicenter Phase II Trial of Neoadjuvant JS001, or JS001 in Combination With Chemotherapy in Resectable NSCLC.

JS001 (Toripalimab) is a recombinant humanized anti-PD-1 monoclonal antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2. The purpose of this study is to studying neoadjuvant JS001, or JS001 in combination with pemetrexed and carboplatin to see how well it works in treating patients with resectable NSCLC.

Read the detailed description

Surgery in combination with preoperative or postoperative chemotherapy is the recommended therapeutic approach for patients with resectable non-small cell lung cancer (NSCLC). However, the prognosis of early-stage NSCLC remains to be improved, with 5-year survival rates ranging from 50% for stage IA to 20% for stage IIIA. Antibodies that block the PD-1 protein have provided a major treatment advance in patients with cancer. JS001 (Toripalimab) is a recombinant humanized anti-PD-1 monoclonal antibody, which has shown its efficacy in the treatment of a variety of malignancies. This study is to studying neoadjuvant JS001, or JS001 in combination with chemotherapy to see how well it works in treating patients with resectable NSCLC.

Being tested
JS001, Pemetrexed, Carboplatin, Thoracic Surgery
Keywords
Non-Small Cell Lung Cancer, Neoadjuvant, Programmed Death-1
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.

  • JS001Drug

    Also called Toripalimab

    JS001 was given 240 mg i.v. infusion on Day 1 of each 21-day cycle for 3 cycles.

  • PemetrexedDrug

    Also called Pemetrexed Disodium

    Subjects receive pemetrexed of 500 mg/m^2 administered as IV infusion on Day 1 of each 21-day cycle for 3 cycles.

  • CarboplatinDrug

    Also called CBP

    Subjects receive carboplatin at the AUC of 5 administered as IV infusion on Day 1 of each 21-day cycle for 3 cycles.

  • Thoracic SurgeryProcedure or surgery

    Surgery will be performed at least 21 days after the last dose of neoadjuvant therapy.

Study groups in NCT03623776
Study groupRoleWhat they receive
JS001 aloneExperimentalSubjects receive JS001 240 mg i.v. infusion on Day 1 of each 21-day cycle for 3 cycles.
Receives: Drug: JS001; Procedure: Thoracic Surgery
JS001+chemotherapyExperimentalSubjects receive JS001 240 mg, pemetrexed of 500 mg/m^2 and carboplatin at the AUC of 5 administered as IV infusion on Day 1 of each 21-day cycle for 3 cycles.
Receives: Drug: JS001; Drug: Pemetrexed; Drug: Carboplatin; Procedure: Thoracic Surgery

What is being measured

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

  1. 3-year Disease Free Survival

    Disease-free survival was assessed from registration to disease recurrence or death as a result of any cause.

    Measured: 3 years after the last patient is registered

Secondary outcomes (4)

  1. Number of participants with treatment-related adverse events (AEs)

    Adverse Events were monitored according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.

    Measured: 2 years after the last patient is registered

  2. Number of participants with perioperative complications

    Perioperative complications will be recorded

    Measured: 2 years

  3. 3-year Overall survival

    Overall survival was assessed from registration to death as a result of any cause.

    Measured: 3 years after the last patient is registered

  4. Pathologic Response

    To assess pathologic response to neoadjuvant JS001, or JS001 in combination with chemotherapy in resected tumor and lymph nodes. Major pathologic response was defined as <10% residual viable tumor cells in the resection specimen.

    Measured: 3 months

Timeline

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

  1. First posted9 Aug 2018
  2. Study start1 Feb 2019
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Why it stopped: No patients enrolled.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03623776
Sponsor's protocol ID
GASTO1038
Acronym
NAJSCR
Status last verified
Dec 2024
First submitted
30 Jul 2018
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JS001, Pemetrexed and Carboplatin in people with Efficacy and Safety, 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 12 inclusion and 15 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: withdrawn, as of the sponsor's last update on 6 Dec 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

3-year Disease Free Survival (time frame: 3 years after the last patient is registered). 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 NCT03623776.

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 6 Dec 2024.

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