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Non Small Cell Lung CancerPhase 3NCT04772287

Adjuvant Toripalimab Plus Chemotherapy for EGFR/ALK Mutation Negative Stage II-IIIB(N2) NSCLC (LungMate-008)

A Phase 3 study testing Toripalimab in people with Non Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This is a randomized, controlled, double-blind, single-center Phase III clinical study in patients with EGFR/ALK mutation negative stage II-IIIB (N2) non-small cell lung cancer (NSCLC) after complete tumor resection. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
341 participants
Where
No sites listed yet
Study dates
31 Mar 2021to 30 Dec 2027
Phase
Phase 3
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Volunteer to participate in this clinical study, understand the research procedures and be able to sign written informed consent.
  • Age ≥18 years old.
  • Histological diagnosis of primary non-small cell lung cancer (NSCLC).
  • An MRI or CT scan of the brain must be performed before lung cancer resection, and it is confirmed that there is no brain metastasis. For patients who have not been examined before surgery, if they have a brain MRI or CT scan before randomization and it is confirmed that there is no brain metastasis, they can still be enrolled.
  • Total resection of primary lung cancer (R0) and systemic lymph node dissection must be performed: complete resection includes lobectomy, sleeve resection, and bilobectomy; systemic lymph node dissection includes hilar and mediastinal lymph node dissection Or sampling, including at least 6 groups of lymph nodes, of which 3 groups are from intrapulmonary (lobar, interlobar or segment) and hilar lymph nodes, and 3 groups are from mediastinal lymph nodes including subcarinal lymph nodes; all surgical margins must be tumor-negative; respectively; The removed mediastinal lymph nodes or the marginal lymph nodes of the removed lung lobes cannot have extranodal invasion.
  • Postoperative pathologically confirmed NSCLC patients with stage II, IIIA and IIIB (N2), the disease is staged according to the American Joint Committee on Cancer (AJCC) 8th edition lung cancer staging standard.
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  • Confirmed as negative for EGFR/ALK mutation.
  • Complete recovery from surgery during randomization, and complete postoperative wound healing must be achieved after any surgery;
  • The Eastern Cooperative Oncology Group (ECOG) physical status (PS) score is 0 or 1 and has not deteriorated 2 weeks before the first administration of the study drug, and the minimum expected survival is greater than 12 weeks.
  • Other major organs (liver, kidney, blood system, etc.) function well:
  • Absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet ≥100×10^9/L, hemoglobin ≥90 g/L. Note: Patients shall not receive blood transfusion or growth factor support within 14 days before blood collection during the screening period;
  • International normalized ratio (INR) or prothrombin time (PT)≤1.5×upper limit of normal (ULN);
  • Activated partial thromboplastin time (APTT)≤1.5×ULN;
  • Serum total bilirubin≤1.5×ULN (total bilirubin in patients with Gilbert syndrome must be <3×ULN);
  • Aspartic acid and alanine aminotransferase (AST and ALT) ≤2.5×ULN
  • Female patients of childbearing age are willing to take appropriate contraceptive measures (Appendix K) and should not breastfeed from signing informed consent to the end of the study medication within 6 months (whichever occurs later); male patients are effective from signing informed consent Willingness to use barrier contraception (i.e. condoms) within 6 months of the end of sexual evaluation/study medication (whichever occurs later).
  • Female patients have a negative blood pregnancy test result within 7 days before randomization, or meet one of the following criteria to prove that there is no risk of pregnancy:
  • Postmenopausal is defined as amenorrhea at least 12 months after the age is greater than or equal to 50 years and all exogenous hormone replacement therapy is stopped;
  • Women younger than 50 years old, if you stop all exogenous hormone treatments and have amenorrhea for 12 months or more, and the levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) are within the reference range of postmenopausal laboratory Can be considered post-menopausal;
  • Have received irreversible sterilization, including hysterectomy, bilateral ovarian removal, or bilateral fallopian tube resection, except for bilateral tubal ligation.

Who cannot join

  • Unresectable or metastatic disease, pathology report showing positive surgical margins or extranodal invasion under the microscope, or leftover lesions during surgery.
  • Patients with lung adenocarcinoma with clear EGFR mutation or ALK rearrangement.
  • Upper sulcus lung cancer.
  • Only patients undergoing segmental resection or wedge resection.
  • Because NSCLC has previously received any anti-cancer treatment other than surgery, including preoperative and postoperative chemotherapy, radiotherapy, targeted therapy (such as small molecule tyrosine kinase inhibitors targeting EGFR, VEGFR and other pathways, monoclonal Antibodies, etc.), immunotherapy, research therapy, etc.; within 14 days before the first administration of the research drug, Chinese medicines and Chinese medicine preparations with anti-tumor therapy indications or tumor adjuvant therapy effects have been used;
  • Suffered from other malignant tumors before the start of the trial, except for the following medical history:
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  • Malignant tumors that have been cured, have been inactive for more than 5 years and have a very low risk of recurrence before being selected for the study;
  • Adequately treated non-melanoma skin cancer or malignant lentigines with no evidence of disease recurrence;
  • Carcinoma in situ with adequate treatment and no evidence of disease recurrence;
  • Localized prostate cancer after radical surgery.
  • Complicated with unstable systemic diseases, including active infections, uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg), unstable angina pectoris, attacks that have started within the last 3 months Angina pectoris, congestive heart failure (≥ New York Heart Association [NYHA] level II), myocardial infarction (6 months before enrollment), severe arrhythmia requiring medication, liver, kidney or metabolic diseases;
  • Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndromes that require systemic treatment;
  • Subjects who have used corticosteroids (>10 mg/day of prednisone or other equivalent hormones) or other immunosuppressive agents for systemic treatment within 2 weeks before the first administration. In the absence of active autoimmune diseases, inhaled or topical corticosteroids are allowed, and adrenal hormone replacement therapy with a dose of ≤10 mg/day prednisone is allowed;
  • Have significant clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before the first administration, such as gastrointestinal bleeding, gastric ulcer bleeding, active hemoptysis or vasculitis.
  • Arteriovenous thrombosis, such as deep vein thrombosis, pulmonary embolism, etc. occurred within 3 months before the first administration (except for implantable venous port, catheter-derived thrombosis or superficial venous thrombosis, these cases Not considered as "severe" thromboembolism).
  • Diabetic ketoacidosis or hyperglycemia and hyperosmotic state occurred within 6 months before the first administration; fasting blood glucose during the screening period Diabetic patients with ≥7.8 mmol/L or glycosylated hemoglobin test value ≥7.5%.
  • It has been known that there are active infectious diseases, such as active hepatitis B (the virus surface antigen [HBsAg] test result in the screening period is positive and the HBV-DNA test value is ≥2×103 IU/mL) or hepatitis C (defined as the screening period) Hepatitis C virus antibody [HCV-Ab] test result is positive, and HCV-RNA is positive), tuberculosis (there is evidence of active tuberculosis infection within 1 year), syphilis (positive Treponema pallidum specific antibodies and non-specific antibodies), or human immunodeficiency Viral HIV infection (anti-HIV antibody positive), etc.
  • Allergic to test drugs.
  • Previously or currently suffering from interstitial lung disease.
  • Women who are pregnant or breastfeeding.
  • People with neurological diseases or mental illnesses who cannot cooperate.
  • At the same time participate in another therapeutic clinical research.
  • Other situations considered unsuitable by researchers.

About this study

Official title: Adjuvant Toripalimab Versus Placebo Combined With Chemotherapy for EGFR/ALK Mutation Negative Stage II-IIIB(N2) Non-small-cell Lung Cancer (LungMate-008): a Randomised, Double-blind, Controlled, Phase 3 Trial

This is a randomized, controlled, double-blind, single-center Phase III clinical study in patients with EGFR/ALK mutation negative stage II-IIIB (N2) non-small cell lung cancer (NSCLC) after complete tumor resection. To evaluate the effectiveness and safety of toripalimab compared with placebo combined with platinum-containing dual-drug chemotherapy.

Being tested
Toripalimab, Toripalimab mimetic (placebo)
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.

  • ToripalimabDrug

    Also called Cisplatin/Carboplatin, Pemetrexed (non-squamous cell carcinoma)/ Docetaxel/ Gemcitabine/ Vinorelbine/ Paclitaxel

    Toripalimab: 240mg, IV, q3w, 4 cycles in total; Platinum-containing dual-drug chemotherapy: The specific dose is based on the standard of the selected protocol, IV, q3w, a total of 4 cycles.

  • Toripalimab mimetic (placebo)Drug

    Also called Cisplatin/Carboplatin, Pemetrexed (non-squamous cell carcinoma)/ Docetaxel/ Gemcitabine/ Vinorelbine/ Paclitaxel

    Placebo: 240mg, IV, q3w, 4 cycles in total; Platinum-containing dual-drug chemotherapy: The specific dose is based on the standard of the selected protocol, IV, q3w, a total of 4 cycles.

Study groups in NCT04772287
Study groupRoleWhat they receive
ToripalimabExperimentalNot described
Receives: Drug: Toripalimab
PlaceboPlacebo comparatorNot described
Receives: Drug: Toripalimab mimetic (placebo)

What is being measured

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

  1. Disease-free survival (DFS)

    It refers to the time from radical surgery to relapse or death of a participant due to disease progression. In the case of a patient who still survives at the time of analysis, the latest evaluation date will be used for interpolation (censoring).

    Measured: up to 40 months

Secondary outcomes (4)

  1. Overall survival (OS)

    It is defined as the time 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.

    Measured: up to 60 months

  2. Safety: frequency of severe adverse events

    The frequency of severe adverse events from the participants enrolling to 90 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.

    Measured: up to 18 months

  3. Health related quality of life (HRQol)

    The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 \& LC13, Version 3). EORTC's QLQ-C30 \& LC13 (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. The other 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.

    Measured: up to 12 months

  4. 5-year overall survival rate

    Five-year survival rate measures survival at 5 years after treatment.

    Measured: From the completion of the intervention to 5 years.

Timeline

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

  1. First posted26 Feb 2021
  2. Study start31 Mar 2021 (estimated)
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2027 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
341 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04772287
Sponsor's protocol ID
LungMate-008
Status last verified
Feb 2021
First submitted
23 Feb 2021
Last updated
26 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Toripalimab in people with Non Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, 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 20 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: opening soon, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

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?

Disease-free survival (DFS) (time frame: up to 40 months). 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 NCT04772287.

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 26 Feb 2021.

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