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Non Small Cell Lung CancerPhase 2NCT04379739

Neoadjuvant PD-1 Antibody Plus Apatinib or Chemotherapy for Non-small Cell Lung Cancer

A Phase 2 study testing Camrelizumab in people with Non Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Immunotherapy with anti-programmed death 1 (PD-1) antibodies has revolutionized the treatment of metastatic and advanced NSCLC, but its application in neoadjuvant setting has not been well established. Results from a pilot clinical study reported the safety and feasibility of neoadjuvant PD-1 blockade. 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?
Camrelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
1 siteChina
Study dates
26 Jul 2020to 30 Dec 2026
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Group A:
  • Aged 18-75 years;
  • Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1;
  • Histological or cytological diagnosis of NSCLC by needle biopsy, and clinical stage II-III according to the TNM classification (8th edition) validated by radiological examination or EBUS;
  • At least 1 measurable lesion according to RECIST 1.1;
  • Life expectancy is at least 12 weeks;
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  • Adequate hematological function, liver function and renal function:
  • Hemoglobin ≤ 90 g/L (which can be maintained or exceeded by blood transfusion);
  • Absolute neutrophil count (ANC) ≤ 1.5 *10^9/L;
  • Platelet count ≤ 100 * 10^9/L;
  • Total bilirubin ≤ 1.5 times of upper limit of normal (ULN);
  • Alanine glutamate transaminase (ALT), straw glutamate transaminase (AST) and alkaline phosphatase (ALP) ≤ 2.5 * ULN;
  • Creatinine ≤ 1.5 * ULN, Creatinine clearance rate ≤ 60ml/min;
  • The international standardized ratio of prothrombin time (INR) ≤ 1.5 R in patients who have not received anticoagulation therapy, and the partial thrombin time (APTT) ≤ 1.5 * ULN.
  • Without systemic metastasis (including M1a, M1b and M1c);
  • With the expectation of radical surgery therapy, or with the expectation of complete resection after treatment;
  • Patients with normal lung function can tolerate surgery;
  • The child-bearing female must undergo pregnancy test (serum or urine) within 72 hours before drug administrating and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 90 days after the last dosage of the drug. The male participants whose partners are child-bearing shall use condom for contraception during the trial and within 30 days after completion of the trial;
  • Signed and dated informed consent.
  • Group B:
  • Aged 18-75 years;
  • Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1;
  • Histological or cytological diagnosis of NSCLC by needle biopsy, and clinical stage II-III according to the TNM classification (8th edition) validated by radiological examination or EBUS;
  • Enough tumor samples from biopsy to testing PD-L1 expression level, and PD-L1 ≥ 1%
  • At least 1 measurable lesion according to RECIST 1.1;
  • Life expectancy is at least 12 weeks;
  • Adequate hematological function, liver function and renal function:
  • Hemoglobin ≤ 90 g/L (which can be maintained or exceeded by blood transfusion);
  • Absolute neutrophil count (ANC) ≤ 1.5 *10^9/L;
  • Platelet count ≤ 100 * 10^9/L;
  • Total bilirubin ≤ 1.5 times of upper limit of normal (ULN);
  • Alanine glutamate transaminase (ALT), straw glutamate transaminase (AST) and alkaline phosphatase (ALP) ≤ 2.5 * ULN;
  • Creatinine ≤ 1.5 * ULN, Creatinine clearance rate ≤ 60ml/min;
  • The international standardized ratio of prothrombin time (INR) ≤ 1.5 R in patients who have not received anticoagulation therapy, and the partial thrombin time (APTT) ≤ 1.5 * ULN.
  • Without systemic metastasis (including M1a, M1b and M1c);
  • With the expectation of radical surgery therapy, or with the expectation of complete resection after treatment;
  • Patients with normal lung function can tolerate surgery;
  • The child-bearing female must undergo pregnancy test (serum or urine) within 72 hours before drug administrating and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 90 days after the last dosage of the drug. The male participants whose partners are child-bearing shall use condom for contraception during the trial and within 30 days after completion of the trial;
  • Signed and dated informed consent.

Who cannot join

  • Group A:
  • The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment, immunotherapy or Chinese medicine treatment, etc. (excluding the malignant tumors that were resected radically and did not recurrent more than 5 years);
  • Non-squamous cell carcinoma with EGFR active mutation positive or ALK rearrangement;
  • The patient suffered from other cancers (except cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor [including Ta and Tis]) within 5 years before the enrollment;
  • The patient suffers from any active autoimmune disease or have the history of autoimmune disease, such as uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy), tuberculosis; Note: The patients with complete remission of childhood asthma and without any interventions in adult life could be included. The patients with skin diseases (like vitiligo, psoriasis or alopecia) who do not need systematic therapy could be included.
  • Suffering or having the history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiological pneumonia, drug-induced pneumonia, radiologically confirmed active pneumonia, or severe impairment of lung function;
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  • Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids >10 mg/ day) or other immunosuppressive agents within 2 weeks prior to first administration. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy with a dose of less than 10 mg/ day of prednisone are permitted;
  • Allergy to the test drug;
  • The patient is a carrier of active hepatitis B, hepatitis C or HIV;
  • Pregnancy or breast-feeding women; child-bearing participants who could not or are unwilling to take contraceptive measures.
  • Patients with eurological or psychiatric disorders history were lack of treatment compliance;
  • Other situations in which investigators thought the patients not suit to be included.
  • Group B:
  • The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment, immunotherapy or Chinese medicine treatment, etc. (excluding the malignant tumors that were resected radically and did not recurrent more than 5 years);
  • Non-squamous cell carcinoma with EGFR active mutation positive or ALK rearrangement;
  • The patient suffered from other cancers (except cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor [including Ta and Tis]) within 5 years before the enrollment;
  • The patient suffers from any active autoimmune disease or have the history of autoimmune disease, such as uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy), tuberculosis; Note: The patients with complete remission of childhood asthma and without any interventions in adult life could be included. The patients with skin diseases (like vitiligo, psoriasis or alopecia) who do not need systematic therapy could be included.
  • Suffering or having the history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiological pneumonia, drug-induced pneumonia, radiologically confirmed active pneumonia, or severe impairment of lung function;
  • Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids >10 mg/ day) or other immunosuppressive agents within 2 weeks prior to first administration. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy with a dose of less than 10 mg/ day of prednisone are permitted;
  • Imaging (CT or MRI) shows that the tumor has invaded or blurred the boundary with the great vessels;
  • The participants who suffered thrombus events, such as stroke (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
  • Having clinically significant bleeding symptoms or had definite bleeding tendency, such as gastrointestinal bleeding or bleeding ulcer, or were receiving thrombolytic therapy or anticoagulant therapy within 3 months before enrollment;
  • Having symptoms of obvious hemoptysis or daily hemoptysis of 2.5ml or more within 1 month before enrollment;
  • Participants with hypertension and unable to obtain good control with antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); Grade II or larger myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interphase, male ≥ 450ms, female ≥ 470ms); According to NYHA, grade Ⅲ ~ Ⅳ cardiac insufficiency, or left ventricular ejection fraction (LVEF) < 50%;
  • The participants have undergone other major systemic operations or suffered from severe trauma within 2 months before the enrollment;
  • Urinary protein ≥ ++, or urinary protein ≥1g at 24h or severe liver and kidney dysfunction;
  • Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
  • Allergy to the test drug;
  • The patient is a carrier of active hepatitis B, hepatitis C or HIV;
  • Pregnancy or breast-feeding women; child-bearing participants who could not or are unwilling to take contraceptive measures.
  • Patients with eurological or psychiatric disorders history were lack of treatment compliance;
  • Other situations in which investigators thought the patients not suit to be included.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Pulmonary Hospital

    Shang'ai, Shanghai Municipality, 200433

Other trials in China

About this study

Official title: Neoadjuvant Camrelizumab Plus Apatinib or Platinum-based Chemotherapy for Potentially Resectable (Resectable and Initially Unresectable) II-III Non-small Cell Lung Cancer

Immunotherapy with anti-programmed death 1 (PD-1) antibodies has revolutionized the treatment of metastatic and advanced NSCLC, but its application in neoadjuvant setting has not been well established. Results from a pilot clinical study reported the safety and feasibility of neoadjuvant PD-1 blockade. There are several neoadjuvant immunotherapy (NEOSTAR, LCMC3, NADIM, IMpower131) ongoing, and the preliminary results are reported in 2019 American Society of Clinical Oncology, which show promising therapeutic prospect. However, the therapeutic response rate (major pathologic response [MPR]) are not so good (20% - 45%) for PD-1 inhibitor monotherapy. To improve the therapeutic response, the investigators design a multiple-canter, open-label, phase II trial for stage II-III potentially resectable (resectable and initially unresectale) NSCLC. The participants will receive neoadjuvant PD-1 inhibitor (camrelizumab) combined with antiangiogenic drug (apatinib) or platinum-based chemotherapy.

Read the detailed description

Detailed Description:

This is a multiple-canter, open-label, phase II trial, 2-4 cycles treatment will be planned as neo-adjuvant therapy for NSCLC participants in stage II-III.

Study design:

Participants: Newly diagnosed Resectable and Initially Unresectale II-III NSCLC without EGFR/ALK mutation.

Treatment:

Group A：camrelizumab 200 mg q3w i.v. for 2-4 cycles, platinum-based chemotherapy q3w i.v for 2-4 cycles before surgery.

Group B：camrelizumab 200 mg q3w i.v. for 2-4 cycles, apatinib 250mg qd po 3w/cycle for 2-4 cycles before surgery;

Endpoints:

Primary objectives are to assess MPR and safety. Secondary objective is to assess 2-year overall survival (OS), disease-free survival (DFS), OS etc.

Exploratory end point is to explore biomarkers.

Being tested
Camrelizumab
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.

  • CamrelizumabDrug

    Also called Apatinib, Platinum-based chemotherapy

    camrelizumab 200mg, q3w, i.v., 2-4 cycles;

Study groups in NCT04379739
Study groupRoleWhat they receive
camrelizumab + apatinibExperimentalNeoadjuvant treatment stage: camrelizumab 200mg, q3w, i.v., 2-4 cycles; apatinib 250 mg, qd, p.o. 3 weeks per cycle, 2-4 cycles, then receive chest CT evaluation. Surgery stage: the patients will receive radical surgery 3-4 weeks after the neoadjuvant treatment. Adjuvant treatment stage: according to the NCCN guidelines.
Receives: Drug: Camrelizumab
camrelizumab + platinum-based chemotherapyExperimentalNeoadjuvant treatment stage: camrelizumab 200mg, q3w, i.v., 2-4 cycles; platinum-based chemotherapy (squamous: carboplatin AUC5, gemcitabine 1000mg/m2; non-squamous: carboplatin AUC5, pemetrexed 500mg/m2) q3w, i.v., 2-4 cycles, then receive chest CT evaluation. Surgery stage: the patients will receive radical surgery 3-4 weeks after the neoadjuvant treatment. Adjuvant treatment stage: according to the NCCN guidelines.
Receives: Drug: Camrelizumab

What is being measured

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

  1. Major pathologic response (MPR)

    MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery.

    Measured: up to 5 months

Secondary outcomes (5)

  1. 2-year OS

    It is defined as the time from enrollment to death of participant due to any cause in 2 years. 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 27 months

  2. Objective response rate (ORR)

    It refers to the proportion of patients who have had a complete response or partial response (according to RECIST1.1) as confirmed by CT evaluation after 3 weeks in all patients who have completed the neoadjuvant therapy. Only patients with measurable lesions at baseline will be analyzed.

    Measured: up to 4 months

  3. 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 60 months

  4. 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. In the event of a patient with the survival status unknown, the date when the patient is last known to be alive will be used for interpolation (censoring).

    Measured: up to 63 months

  5. 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 6 months

Timeline

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

  1. First posted7 May 2020
  2. Study start26 Jul 2020
  3. Primary completion29 Jun 2022
  4. Study completion30 Dec 2026 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04379739
Sponsor's protocol ID
MA-NSCLC-II-001 (LungMate-003)
Status last verified
Nov 2023
First submitted
19 Apr 2020
Last updated
6 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The researchers will consider whether IPD is available to other researchers only after the paper is published.

Publications

  • Ji S, Sheng Z, Bian D, Bao M, Jin K, Zhang W, Zhu X, Sun F, Xia H, Zhang H, Shen Z, Yu H, Zhang L, Huang J, Peng Z, Song N, Wang H, Qian B, Zhu Y. Neoadjuvant camrelizumab plus chemotherapy or apatinib for resectable stage IIA-IIIA NSCLC: a multicenter, two-arm, phase II exploratory trial. BMC Med. 2025 Jul 18;23(1):429. doi: 10.1186/s12916-025-04250-4.

    PubMed 40682106

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab in people with Non Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China 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 39 inclusion and 32 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: under way, not looking for participants, as of the sponsor's last update on 6 Dec 2023. 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?

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?

Major pathologic response (MPR) (time frame: up to 5 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 NCT04379739, which also lists 1 linked publication.

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 2023.

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