Neoadjuvant Toripalimab for Non-squamous NSCLC With EGFR Mutation

NCT05962021 | Not Yet Recruiting Phase 2

• 1 other identifier: JS001-ISS-CO413
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was designed to investigate the efficacy and safety of neoadjuvant Toripalimab (anti-PD1) plus chemotherapy for patients with resectable II-IIIB non-squamous NSCLC harboring EGFR mutation, and to explore the potential predictive and prognostic biomarkers, aiming to provide more abundant evidences for the preoperative treatment decision of non-squamous NSCLC patients.

Conditions

Non Squamous Non Small Cell Lung Cancer; EGFR Positive Non-small Cell Lung Cancer

Keywords

Non squamous non small cell lung cancer; EGFR Mutation; Neoadjuvant immuno-chemotherapy; Predictive and prognostic biomarker

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response (pCR) Rate

  Pathologic complete response (pCR) rate is defined as the percentage of participants with no residual viable tumor in lung primary or lymph nodes as evaluated by blinded independent pathological review (BIPR).

  Within 1 week after surgery

Secondary Outcomes (7)

• Major Pathologic Response (MPR) Rate

  Within 1 week after surgery

• Pathologic Complete Response (pCR) Rate in non-squamous NSCLC with different EGFR mutations status

  Within 1 week after surgery

• Major Pathologic Response (MPR) Rate in non-squamous NSCLC with different EGFR mutations status

  Within 1 week after surgery

• Pathologic Complete Response (pCR) Rate in non-squamous NSCLC with different PD-L1 expression levels

  Within 1 week after surgery

• Major Pathologic Response (MPR) Rate in non-squamous NSCLC with different PD-L1 expression levels

  Within 1 week after surgery

Study Arms (2)

19DEL cohort

EXPERIMENTAL

Patients who participated in the trial with EGFR 19DEL mutation will be included in this arm.

Drug: Toripalimab plus Chemotherapy

L858R cohort

EXPERIMENTAL

Patients who participated in the trial with EGFR L858R mutation will be included in this arm

Drug: Toripalimab plus Chemotherapy

Interventions

Toripalimab plus Chemotherapy DRUG

Therapy was administered on a 21-day regimen for 3 cycles, with Toripalimab (240mg, d1), carboplatin (AUC=5, d1) + pemetrexed (500 mg/m2, d1) for patients with lung adenocarcinoma and carboplatin (AUC=5, d1) + albumin-bound paclitaxel (260 mg/m2, d1) for patients with other subtypes.

19DEL cohort; L858R cohort

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed informed consent by the patient or legally acceptable representative;
• Previously untreated, histologically confirmed resectable stage II-IIIA, IIIB(N2) (AJCC staging 8th edition) non-squamous non-small cell lung cancer;
• Adequate tissue samples for PD-L1 immunohistochemical testing and gene mutations test by RT-pCR or NGS, or consent for blood RT-PCR or NGS if tissue samples are insufficient;
• Harboring EGFR mutation (19del or L858R);
• Aged 18-70 years, regardless of gender;
• Eastern Cooperative Group (ECOG) Performance Status 0-1;
• Acceptable cardiac function with a left ventricular ejection fraction \>50%;
• Acceptable respiratory function (FEV1\>1.5L, DLCO\>50%) and ability to tolerate radical lung cancer surgery;
• Acceptable bone marrow haematopoiesis with leucocytes ≥ 4 x 10\^9/L, neutrophils ≥ 1.5 x 10\^9/L, haemoglobin ≥ 10g/dL and platelets ≥ 100 x 10\^9/L;
• Acceptable renal function with a glomerular filtration rate ≥ 60 mL/min;
• Acceptable liver function with total bilirubin ≤ 1.5 x ULN, AST ≤ 3 x ULN, and ALT ≤ 3 x ULN;
• Presence of measurable lesions as defined by RECIST 1.1 criteria;
• Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 3 days prior to the start of study treatment, and agree to use effective contraception for the duration of study drug use and for 120 days after the last dose. Women of childbearing potential were defined as sexually mature females who 1) had not undergone hysterectomy or bilateral oophorectomy and 2) had not experienced spontaneous menopause for 12 consecutive months (amenorrhea after cancer treatment did not preclude fertility) (menstruation had occurred at any time during the previous 12 consecutive months).

You may not qualify if:

• Pathological histologically confirmed small cell lung cancer, squamous epithelial cell carcinoma and other pathological subtypes cannot be enrolled;
• Patients with advanced or metastatic lung cancer, or unresectable lung cancer, or who have received previous systemic anti-tumour therapy such as immunotherapy, chemotherapy or targeted therapy cannot be enrolled;
• Patients with a history of active autoimmune disease or autoimmune disease that is likely to recur cannot be enrolled;
• Patients with active hepatitis B and C requiring relevant antiviral therapy need to have HBV-DNA \<500 IU/ml and have been on anti-HBV treatment for at least 14 days prior to study entry and continue treatment during the treatment period; HCV RNA-positive patients should be excluded;
• Patients who are allergic to chemotherapeutic agents such as carboplatin, paclitaxel, albumin paclitaxel, pemetrexed;
• Patients with a history of allergy to monoclonal antibody drugs;
• Patients who have previously received an allogeneic stem cell transplant or organ transplant；
• Patients with mental illness or any other illness that makes it impossible to comply with treatment；
• Patients who are unable or unwilling to sign the informed consent form；
• Patients with comorbidities or other conditions that, in the opinion of the investigator, may affect compliance with the protocol or make them unsuitable for participation in this study.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Shanghai Junshi Bioscience Co., Ltd.: collaborator

MeSH Terms

Interventions

toripalimab; Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Fan Yanf, M.D.

  Peking University People's Hospital

  STUDY CHAIR

Central Study Contacts

Fan Yang, M.D.

CONTACT

+86-010-88326657; yangfan@pkuph.edu.cn

Xiang Yan, M.D.

CONTACT

+86-13581786750; yxiang301@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Thoracic Surgery

Model Details: Patients were divided into the 19del and L858R groups according to their EGFR mutation status.

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 27, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 1, 2023

Record last verified: 2023-07