Camrelizumab Combination With SBRT and Concurrent Chemotherapy Treated Stage IV Oligometastatic Non-small Cell Lung Cancer

NCT05472467 | Unknown Phase 2 DMC

• 1 other identifier: SCCHEC-01-2021-091
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated the effectiveness and safety of Camrelizumab combination with SBRT and concurrent chemotherapy treated stage IV oligometastatic non-small cell lung cancer

Conditions

Non-small Cell Lung Cancer Metastatic

Keywords

NSCLC,Camrelizumab,SBRT,oligometastatic

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective response rate, according to RECISTv1.1, the proportion of patients with CR or PR was determined. If the patient has not undergone a post-baseline assessment, it is considered unremission.

  up to 3 years

Secondary Outcomes (4)

• PFS

  up to 3 years

• OS

  up to 3 years

• HRQoL

  up to 3 years

• HRQoL

  up to 3 years

Study Arms (1)

Immunotherapy combined with Stereotactic Body Radiation Therapy

EXPERIMENTAL

1. Camrelizumab： 200mg IV Q3W 2. Chemotherapy：Squamous carcinoma: docetaxel 60 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6 d1, 21 days for one cycle, up to 4 cycles. Non-squamous carcinoma: pemetrexed 500 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6, d1,21 days for one cycle, up to 4 cycles. 3. Stereotactic Body Radiation Therapy(SBRT) for Oligometastatic the total dose 35Gy/5f(7.0Gy/f,5f per week)。

Drug: Camrelizumab; Radiation: stereotactic body radiation therapy; Drug: Chemotherapy

Interventions

Camrelizumab DRUG

200mg IV Q3W. Every three weeks is a cycle

Immunotherapy combined with Stereotactic Body Radiation Therapy

stereotactic body radiation therapy RADIATION

stereotactic body radiation therapy for Oligometastases 35Gy/5f(7.0Gy/f,5f per week)

Also known as: SBRT

Immunotherapy combined with Stereotactic Body Radiation Therapy

Chemotherapy DRUG

Squamous carcinoma: docetaxel 60 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6 d1, 21 days for one cycle, up to 4 cycles. Non-squamous carcinoma: pemetrexed 500 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6, d1,21 days for one cycle, up to 4 cycles.

Immunotherapy combined with Stereotactic Body Radiation Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients voluntarily enrolled in this study and signed the informed consent form (ICF).
• Good compliance and cooperation with follow-up.
• age: 18 to 75 years, both sexes.
• ECOG PS: 0 to 1 score.
• patients with non-small cell lung cancer clearly diagnosed by pathology, with measurable tumor lesions (oligometastases ≥10 mm in length, meeting mRECIST1.1 criteria).
• subjects with clinical stage IV according to the 8th edition of the Clinical Oncology TNM staging Stage IV (≤5 oligometastases, ≤3 metastatic organs, and measurable metastases) non-small cell lung cancer patients according to the 8th edition of TNM staging.
• \. patients with stage IV clinical stage (number of oligometastases ≤ 5, metastatic organs ≤ 3, and measurable metastases) non-small cell lung cancer 6. vital organ function meets the following requirements (no blood components and cell growth are allowed 2 weeks prior to the start of study treatment) (No blood components or cell growth factors are allowed 2 weeks prior to the start of study treatment).
• (1) Routine blood tests must meet the following requirements.
• absolute neutrophil count (ANC) ≥ 1.5 x 109
• Hemoglobin (HB) ≥ 9 g/dL.
• Platelets (PLT) ≥ 100×109 /L.
• serum albumin (ALB) ≥ 2.8g/dL. (2) Biochemical examination shall comply with.
• a) total bilirubin (TBIL) ≤ 1.5 ULN. b) ALT, AST ≤ 2.5 UILN (if liver function abnormalities due to liver metastases, then ≤ 5 ULN) b) ALT, AST ≤ 2.5 UILN (≤ 5 ULN if liver function abnormalities are due to liver metastasis).
• c) serum creatinine sCr ≤ 1.5 ULN, endogenous creatinine clearance c) serum creatinine sCr ≤ 1.5 ULN and endogenous creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula).
• \. expected survival ≥ 3 months. 8. the patient is judged by the investigator to be amenable to treatment with kallikreinumab 9. the patient has no autoimmune disease. 10. the patient has not received prior treatment with PD-1/PD-L1 inhibitors. 11. tissue or plasma genetic testing for common lung cancer driver genes such as EGFR, ALK, ROS, RET, HER2, MET, BRAF negative, or no accessible targeted drugs or who are intolerant to targeted drug therapy.

You may not qualify if:

• with diffuse brain metastases and meningeal metastases
• have any active autoimmune disease or a history of autoimmune disease such as inter stromal pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after normal hormone replacement therapy).
• may be included after normalization of hormone replacement therapy).
• patients with asthma requiring medical intervention with bronchodilators
• patients with uncontrolled cardiac clinical symptoms or disease, such as. (1) NYHA class II or higher heart failure. (2) Unstable angina pectoris. (3) Myocardial infarction within 1 year. (4) Clinically significant supraventricular or ventricular arrhythmias requiring clinical (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
• active infection or unexplained fever of \>38.5°C (0.5 mg/kg) during screening or before the first dose Fever \>38.5°C (in the judgment of the investigator, subjects with fever due to tumor fever can be enrolled).
• a known history or evidence of interstitial lung disease or active non-infectious pneumonia
• have a congenital or acquired immune deficiency (e.g., HIV-infected), active Hepatitis B (HBV-DNA ≥ 104 copies/mL) or Hepatitis C (Hepatitis C antibody positive and HCV-RNA above the lower limit of detection for the assay).
• prior treatment with other PD-1 monoclonal antibodies or other immunotherapy against PD-1/PDL1
• known hypersensitivity to macromolecular protein agents, or to any of the components of kareolizumab sensitization.
• Requirement for corticosteroids (\>10 mg/day, prednisone) within 14 days prior to first administration of study drug.
• mg/day, prednisone efficacy dose) or other immunosuppressive agents for systemic therapy within 14 days prior to the first Subjects on systemic therapy with corticosteroids (\> 10 mg/day, prednisone efficacy dose) or other immunosuppressive agents within 14 days prior to first study drug administration. In the absence of active autoimmune disease In the absence of active autoimmune disease, inhaled or topical steroids and adrenaline at doses \>10 mg/day, prednisone efficacy dose are allowed.
• Adrenocorticosteroid replacement at efficacious doses of prednisone. 12. have received an antitumor monoclonal antibody (mAb) within 4 weeks prior to the first administration of study drug (mAb) within 4 weeks prior to the first administration of study drug, or adverse events from previously received drugs have not Recovery (i.e., ≤ grade 1 or at baseline level). Note: Occurrence of ≤ grade 2 neuropathy or ≤ grade 2 alopecia.
• Note: Subjects with ≤ grade 2 neuropathy or ≤ grade 2 alopecia are excluded if the subject has undergone major surgery.
• If the subject has undergone major surgery, the toxic effects and/or complications of the surgical intervention must be adequately addressed prior to initiation of treatment.

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

Sichuan Cancer Hospital & Institute

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

camrelizumab; Radiosurgery; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Tao Li, doctor

  Sichuan Cancer Hospital and Research Institute

  STUDY CHAIR

Central Study Contacts

jiahua lyu, doctor

CONTACT

17713539529; winlttljh@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Head

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 25, 2022
• Study Start: December 21, 2021
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)