EGFR-TKIs Plus PD-1 in EGFR-Mutant Advanced NSCLC

NCT07637448 | Recruiting Phase 2

• 1 other identifier: NFEC-2026-076
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label, multicenter, single-arm clinical study.

Conditions

Lung Cancer Non-Small Cell Cancer (NSCLC); EGFR Activating Mutation; PD-1 Antibody

Keywords

Non-Small Cell Cancer (NSCLC); EGFR-Mutant; EGFR-TKIs; PD-1 Monoclonal Antibody

Outcome Measures

Primary Outcomes (1)

• Median Progression-free survival

  from randomization (or initiation of treatment) to the first occurrence of disease progression or death from any cause.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Secondary Outcomes (4)

• objective response rate

  through study completion, an average of 3 years.

• Disease Control Rate

  through study completion, an average of 3 years.

• Median Overall Survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

• The incidence and severity of treatment-related adverse events (AEs) and serious adverse events (SAEs) assessed according to NCI CTCAE v5.0, as well as laboratory abnormalities.

  through study completion, an average of 3 years.

Study Arms (1)

EGFR-TKIs Combined with PD-1 Monoclonal Antibody

EXPERIMENTAL

All patients receive first-line oral therapy with standard-dose third-generation EGFR-TKIs (osimertinib, aumolertinib, or furmonertinib). Once stable disease is confirmed by two consecutive radiological assessments, sintilimab (200 mg intravenously every three weeks) is added as maintenance treatment until disease progression, unacceptable toxicity, or a maximum treatment duration of two years.

Drug: EGFR-TKIs Combined with PD-1 Monoclonal Antibody

Interventions

EGFR-TKIs Combined with PD-1 Monoclonal Antibody DRUG

EGFR-TKIs Combined with PD-1 Monoclonal Antibody

EGFR-TKIs Combined with PD-1 Monoclonal Antibody

Eligibility Criteria

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

You may qualify if:

• Patients with histologically or cytologically confirmed, previously untreated EGFR-mutant (19del/L858R) locally advanced or metastatic (stage IIIB/IIIC or IV) non-small cell lung cancer (NSCLC), according to the 9th edition of the TNM staging system for lung cancer jointly issued by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC);
• Male or female patients aged ≥ 18 years;
• Patients who are willing to receive third-generation EGFR-TKI targeted therapy, followed by maintenance therapy with a PD-1 antibody during the stable phase of the disease (defined as no further tumor shrinkage for at least two consecutive assessments based on RECIST v1.1 criteria);
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• At least one measurable or non-measurable but evaluable lesion according to RECIST version 1.1;
• Adequate organ function;
• Female or male patients of childbearing potential must agree to use highly effective contraceptive measures throughout the study period;
• Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements as specified in the visit schedule.

You may not qualify if:

• Patients who are ineligible for standard anti-tumor therapy according to routine clinical practice;
• Prior treatment with anti-PD-1/PD-L1 immunotherapy;
• Concurrent enrollment in another clinical study;
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Receipt of systemic corticosteroids or other immunosuppressive therapy within 2 weeks prior to the first dose of study drug;
• Receipt of any live vaccine within 4 weeks prior to the first dose of study drug, or planned receipt of live vaccine during the study period;
• Presence of brainstem, leptomeningeal, spinal cord metastasis, or spinal cord compression;
• Presence of uncontrolled concomitant diseases, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, etc.;
• History of severe gastrointestinal ulcer, gastrointestinal perforation, fistula or obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose, or other gastrointestinal diseases that, in the investigator's opinion, may predispose to bleeding or perforation;
• Presence of severe uncontrolled cardiovascular disease;
• Interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis) requiring corticosteroid therapy, or current ILD/non-infectious pneumonitis;
• Concomitant pulmonary disease resulting in clinically severe impairment of respiratory function;
• Chronic autoimmune disease or inflammatory disease requiring systemic therapy or receiving systemic therapy within 2 years prior to the first dose;
• Active or history of documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea), intestinal obstruction, or extensive bowel resection;
• Diagnosis of Gilbert's syndrome;

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Southern Medical University Nanfang Hospital Department of Oncology

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 9, 2026
• Study Start: May 21, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)