Standard-of-care Systemic Therapy With or Without Local Therapy in Patients With Oligoprogressive Non-Small Cell Lung Cancer(NSCLC）

NCT07076693 | Active Not Recruiting Phase 2

• 1 other identifier: IS25085
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, controlled, phase II/III clinical study to evaluate the efficacy and safety of stand-of-care systemic therapy with local therapy versus stand-of-care systemic therapy in patients with oligoprogressive non-small cell lung cancer(NSCLC).

Conditions

OligoProgressive Metastatic Disease; Non-Small Cell Lung Cancer

Keywords

oligopregressive disease; local therapy; non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)

  The proportion of patients achieving complete remission (CR) or partial remission (PR)

  up to 7 weeks after standard subsequent-line therapy

• Progression-free survival (PFS)

  Time from randomization to disease progression or death

  up to 3 years

Secondary Outcomes (5)

• Overall survival (OS)

  up to 3 years

• Local Control (LC)

  up to 3 years

• Adverse Events (AE)

  up to 3 years

• local treatment tolerability

  up to 3 years

• treatment failure pattern

  up to 3 years

Study Arms (2)

Experimental

EXPERIMENTAL

For patients with oligoprogressive disease, local treatment (radiotherapy or surgery) is administered to all/partial oligoprogressive sites while providing standard systemic therapy for 4-6 cycles. Radiotherapy is administered with radiation dose 30-50Gy. The site and regimen of radiotherapy or surgery are primarily determined by the investigator. Maintenance therapy or not is determined by investigator assessment after evaluation .

Procedure: Radiotherapy or Surgery; Drug: Standard Medical Therapy

Active Comparator

ACTIVE COMPARATOR

Standard systemic therapy is administered for 4-6 cycles. Maintenance therapy or not is determined by investigator assessment after evaluation.

Drug: Standard Medical Therapy

Interventions

Radiotherapy or Surgery PROCEDURE

Metastatic lesions were treated with surgical resection or radiotherapy. Surgical duration was determined by investigator assessment and metastatic or primary lesions were resected with palliative intent. Radiation dose and fractionation are 30\~50Gy. Radiation dose, fractionation regimen, and treatment sites for metastatic lesions were determined at the investigator's discretion based on clinical indications.

Experimental

Standard Medical Therapy DRUG

Patients with squamous cell carcinoma received docetaxel administered in 3-week cycles, and patients with adenocarcinoma received pemetrexed, patinum and one of sintilimab or ivonescimab.

Active Comparator; Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign a written informed consent form and voluntarily participate in this study;
• Age 18-75 years;
• ECOG 0-1, or able to tolerate radiotherapy/surgery and subsequent systemic therapy;
• For Epidermal Growth Factor Receptor (EGFR)-sensitive mutant non-squamous NSCLC patients, first-line treatment must be the third-generation TKIs or progression after first/second-generation TKI without harboring T790M mutation, with ≤3 progressive lesions and ≤3 metastatic organs (PET-CT + cranial MRI preferred, or comprehensive imaging assessment, pathological examination not mandatory);
• For squamous cell lung cancer patients, progression after first-line immunotherapy/chemotherapy-immunotherapy with ≤3 progressing lesions and ≤3 metastatic organs (PET-CT + cranial MRI preferred, or comprehensive imaging assessment, pathological examination not mandatory);
• Expected survival ≥6 months;
• No severe medical conditions;
• Normal major organ functions, including:
• Blood tests: WBC count ≥4.0×10⁹/L, neutrophil count ≥1.5×10⁹/L, platelet count ≥80×10⁹/L, hemoglobin ≥90 g/L;
• Blood biochemistry: total bilirubin ≤1.5×ULN, ALT ≤2.5×ULN, AST ≤2.5×ULN, serum creatinine ≤1.5×ULN, or creatinine clearance ≥50 mL/min;
• Coagulation function: INR ≤1.5×ULN; APTT ≤1.5×ULN; FEV1 \> 0.75 L;
• All oligoprogressive sites must be tolerable for radiotherapy or surgical treatment; for patients receiving radiotherapy, if prior radiotherapy was administered to the primary lesion, the re-irradiated site must be the metastatic lesions;
• No other primary tumors before treatment;
• PD-L1 expression status and driver gene sensitive mutations are both acceptable;
• At least one evaluable target lesion, with metastases occurring within one month defined as synchronous metastases;

You may not qualify if:

• Large cell neuroendocrine carcinoma, pulmonary carcinoid tumor, or mixed small cell and small cell lung cancer;
• Patients with progressive lesions over 3 lesions;
• Patients with meningeal metastasis, pleural metastasis, or severe pleural/ascitic effusion, or those who had severe pleural effusion during prior treatment but are now controlled;
• Patients with any other current or previous malignancies, except for non-melanoma skin cancer or carcinoma in situ of the cervix;
• Any other disease or condition that contraindicates radiotherapy/chemotherapy/immunotherapy (e.g., active infection, within 6 months after myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia, immunosuppressive therapy);
• Other conditions deemed unsuitable for enrollment by the investigator.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital, Shanghai, Recruiting

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy; Surgical Procedures, Operative

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)

Therapeutics

Study Design

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

Model Details: Parallel

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 22, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)