Lung Cancer Non-Small Cell Cancer (NSCLC)Phase 2NCT07637448
EGFR-TKIs Plus PD-1 in EGFR-Mutant Advanced NSCLC
A Phase 2 study testing EGFR-TKIs Combined with PD-1 Monoclonal Antibody in people with Lung Cancer Non-Small Cell Cancer (NSCLC) and EGFR Activating Mutation, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
This study is an open-label, multicenter, single-arm clinical study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Non-Small Cell Cancer (NSCLC), EGFR Activating Mutation, PD-1 Antibody
- What is being tested?
- EGFR-TKIs Combined with PD-1 Monoclonal Antibody
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2026to 1 Mar 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Severe infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;
- Known active pulmonary tuberculosis;
- Known active syphilis infection;
- Known history of immunodeficiency, or positive test for human immunodeficiency virus (HIV) antibody;
- Presence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
- Known allergy to any component of any study drug, history of severe allergic reactions (e.g., anaphylactic shock), history of severe hypersensitivity to other monoclonal antibodies or recombinant protein-based substances, or history of severe infusion reactions;
- Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study period;
- Any disease, medical condition, organ system dysfunction, or social circumstance (including but not limited to psychiatric illness, substance/alcohol abuse, history of drug abuse, etc.) that, in the investigator's opinion, may interfere with the subject's ability to provide informed consent, adversely affect the subject's cooperation and participation in the study, or confound the interpretation of study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Southern Medical University Nanfang Hospital Department of Oncology
Guangzhou, Guangdong
Professor Wang, +86 20 87150, doc_wang@163.com
About this study
Official title: A Clinical Study Evaluating the Preliminary Antitumor Activity and Safety of EGFR-TKIs Combined With PD-1 Monoclonal Antibody as First-Line Therapy in Patients With EGFR-Mutant Advanced Non-Small Cell Lung Cancer
This study is an open-label, multicenter, single-arm clinical study.
Read the detailed description
This open-label, multicenter, single-arm exploratory clinical trial plans to enroll a total of 32 patients: 6 in a safety lead-in phase and the remaining 26 in an expansion phase. Eligible subjects are treatment-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR 19del or L858R mutations. 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. The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and adverse events occurring throughout treatment. Exploratory analyses focus on the correlation of serum lipid profiles and the tumor immune microenvironment with the safe treatment window and mechanisms of drug resistance. The trial consists of screening, treatment, safety follow-up, and survival follow-up periods. Tumor imaging evaluations are performed every six weeks during the first 24 weeks of treatment and every nine weeks thereafter.
- Being tested
- EGFR-TKIs Combined with PD-1 Monoclonal Antibody
- Keywords
- Non-Small Cell Cancer (NSCLC), EGFR-Mutant, EGFR-TKIs, PD-1 Monoclonal Antibody
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGFR-TKIs Combined with PD-1 Monoclonal AntibodyDrug
EGFR-TKIs Combined with PD-1 Monoclonal Antibody
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: EGFR-TKIs Combined with PD-1 Monoclonal Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression-free survival
from randomization (or initiation of treatment) to the first occurrence of disease progression or death from any cause.
Measured: 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
The proportion of patients whose tumor volume reduction meets predefined criteria (Complete Response or Partial Response) and is maintained for a certain period of time.
Measured: through study completion, an average of 3 years.
Disease Control Rate
The DCR is the percentage of patients achieving CR, PR or SD per RECIST criteria at the first tumor assessment.
Measured: through study completion, an average of 3 years.
Median Overall Survival
the time from randomization (or initiation of treatment) at which 50% of patients have died.
Measured: 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.
Adverse events were graded according to NCI CTCAE v5.0 and collected from the first dose to 30 days after the last dose. Serious adverse events were collected from the signing of informed consent through the end of the study.
Measured: through study completion, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start21 May 2026
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer Non-Small Cell Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637448
- Sponsor's protocol ID
- NFEC-2026-076
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Preliminary Antitumor Activity and Safety of EGFR-TKIs Combined With PD-1 Monoclonal Antibody as First-Line Therapy in Patients With EGFR-Mutant Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07637448
- Acronym / sponsor ID
- NFEC-2026-076
- Keywords
- Non-Small Cell Cancer (NSCLC), EGFR-Mutant, EGFR-TKIs, PD-1 Monoclonal Antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 21 May 2026 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label, multicenter, single-arm clinical study.
Detailed description
This open-label, multicenter, single-arm exploratory clinical trial plans to enroll a total of 32 patients: 6 in a safety lead-in phase and the remaining 26 in an expansion phase. Eligible subjects are treatment-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR 19del or L858R mutations. 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. The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and adverse events occurring throughout treatment. Exploratory analyses focus on the correlation of serum lipid profiles and the tumor immune microenvironment with the safe treatment window and mechanisms of drug resistance. The trial consists of screening, treatment, safety follow-up, and survival follow-up periods. Tumor imaging evaluations are performed every six weeks during the first 24 weeks of treatment and every nine weeks thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGFR-TKIs Combined with PD-1 Monoclonal Antibody | Experimental | Drug: EGFR-TKIs Combined with PD-1 Monoclonal AntibodyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGFR-TKIs Combined with PD-1 Monoclonal AntibodyEGFR-TKIs Combined with PD-1 Monoclonal Antibody | Drug | EGFR-TKIs Combined with PD-1 Monoclonal Antibody |
Primary outcome
Median Progression-free survival
Time frame: 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
from randomization (or initiation of treatment) to the first occurrence of disease progression or death from any cause.
4 secondary outcomes
objective response rate
Time frame: through study completion, an average of 3 years.
Disease Control Rate
Time frame: through study completion, an average of 3 years.
Median Overall Survival
Time frame: 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.
Time frame: through study completion, an average of 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Southern Medical University Nanfang Hospital Department of Oncology
Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EGFR-TKIs Combined with PD-1 Monoclonal Antibody in people with Lung Cancer Non-Small Cell Cancer (NSCLC) and EGFR Activating Mutation, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Progression-free survival (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.