A Phase II Trial of LM103 for Adjuvant Treatment in Patients With Non-small Cell Lung Cancer

Official title

A Multicenter, Randomized, Controlled, Open-label, Phase IIa Trial on Autologous Tumor Infiltrating Lymphocyte Injection (LM103 TILs) for the Adjuvant Treatment of Non-small Cell Lung Cancer With Negative Driver Gene Mutations

Overview

After receiving neoadjuvant treatment with PD-1 antibody and undergoing radical resection, a total 36 to 45 NSCLC patients who met the inclusion criteria, will be randomly assigned in a 1:1:1 ratio to the experimental group 1, experimental group 2 and the control group in this Phase IIa clinical trial. The study will be followed up until 24 to 36 months after treatment.

Interventions

• Biological LM103 TILs Injection
  Extract, culture and expand tumor-infiltrating lymphocytes from resected tumor tissues in vitro for the manufactur of LM103 TILs injection. After NMA-LD, the subjects received LM103 infusion and followed by IL-2 supportive treatment.
• Biological PD-1 / PD-L1 monoclonal antibody
  Received PD-1 antibody treatment according to the instructions.

Primary outcome measures

• Adverse Events (AEs) [Time frame: Maximum 24~36 months]
• Disease Free Survival [Time frame: Every 12 weeks from treatment to 24~36 months]

Eligibility criteria

Inclusion criteria

• At the date of signing Informed Consent Form (ICF), 18 \~75 years old, male or female;
• Expected survival time >3 months;
• ECOG performance status 0-1;
• Pathologically diagnosed as resectable non-small cell lung cancer:

• Received preoperative neoadjuvant therapy (including PD-1 antibody);
• Screening criteria:

i. Driver gene mutations was negative; ii. No disease recurrence (including local recurrence) after surgery; iii. Expected to complete standard adjuvant therapy.

• Patients have lesions that can be used for surgical resection or biopsy puncture;
• Patients have sufficient hematology and organ functions;
• Voluntarily sign a written informed consent form (ICF).

Exclusion criteria

• A history of other malignant tumors within the past 5 years, excluding malignant tumors that can be expected to heal after treatment (including but not limited to well-treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated by radical surgery);
• Adverse reactions caused by previous treatments have not been recovered to grade ≤1 (CTCAE V6.0) (excluding alopecia and neurotoxicity, and hypothyroidism, adrenal insufficiency and hypopituitarism that cannot be restored to grade 2 as determined by the investigators for a long time);
• Any immune-related adverse reaction (irAE) with a severity level greater than grade 3 that has occurred during any previous immunotherapy and has been permanently discontinued;
• Have received vaccination within two months prior to signing the ICF, or plan to receive vaccination during the study;
• Have received TIL cell therapy, allogeneic T cell therapy or NK cell therapy within 6 months prior to signing the ICF;
• Have received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past;
• Suffering from or suspected of having an active autoimmune disease;
• Suffering from a large amount of pleural effusion or ascites with clinical symptoms or requiring symptomatic treatment;
• Patients with current or previous irreversible interstitial lung disease;
• Suffering from serious cardiovascular and cerebrovascular diseases;
• Suffering from an active infection that requires systemic treatment;
• Suffering from infectious diseases such as hepatitis B, hepatitis C, syphilis, AIDS;
• Patients with esophageal or gastric varices requiring immediate intervention (such as ligation or sclerotherapy), or those with a higher risk of bleeding as recommended by the investigator or gastroenterologist or hepatologist, evidence of portal hypertension (including splenomegaly found in imaging examinations), or a history of variceal bleeding must undergo endoscopic assessment within 3 months before enrollment;
• Uncontrolled metabolic disorders, such as diabetes, or other non-malignant organ or systemic diseases or secondary reactions to cancer, can lead to higher medical risks and/or uncertainties in survival assessment;
• Those who are known to be allergic to any component of the investigational drug and the LM103 product formula;
• Women who are pregnant or breastfeeding;
• As determined by the investigators, there are other severe, acute or chronic medical diseases, mental disorders or laboratory abnormalities that may increase the risks related to participation in the study or may interfere with the interpretation of the study results.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 5 centers

• Guangdong Provincial People's Hospital — Guangzhou
• Guangdong Provincial People's Hospital — Guangzhou
• Zhujiang Hospital of Southern Medical University — Guangzhou
• Henan Provincial People's Hospital — Zhengzhou
• The Third People's Hospital of Chengdu — Chengdu

Identifiers

NCT: NCT07444437 · LM103-NSCLC-CT01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗