Can a Triple-Drug combo before surgery eliminate EGFR-Mutant lung cancer?
NCT ID NCT07807722
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This phase II trial tests whether giving a combination of firmonertinib, anlotinib, and chemotherapy before surgery can shrink or eliminate tumors in people with resectable EGFR-mutant non-small cell lung cancer. The study enrolls adults with stage IIA-IIIB disease who have specific EGFR mutations. Participants receive three cycles of the drug combination, then undergo surgery to assess how much tumor remains. The main goal is to measure the rate of major pathological response, meaning less than 10% viable tumor cells left in the removed tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of firmonertinib (an EGFR inhibitor), anlotinib (an anti-angiogenic drug), and chemotherapy (pemetrexed plus carboplatin) given before surgery
- What this could lead to
- If successful, this approach could shrink or eliminate tumors before surgery, potentially increasing the chance of a complete cure for people with early-stage EGFR-mutant lung cancer.
- What could go wrong
- This is a small, early-phase study with only 29 participants, so results may not apply broadly. The combination may cause side effects, and it is not yet known if it will improve long-term outcomes compared to standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 29 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Sep 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. EGFR mutation positive non-small cell lung cancer (including 19Del and 21L858R) confirmed by biopsy 2. Resectable stage IIA-IIIB (8th edition TNM staging) non-small cell lung cancer diagnosed by chest CT, PET-CT, or/and EBUS 3. No systemic metastasis (head MRI, whole-body bone scan PET-CT、 Liver and adrenal CT scans, etc 4. Good lung function, able to tolerate surgical treatment 5. Age 18 and above 6. At least one measurable tumor lesion (with a maximum diameter of 10mm or more as measured by CT) 7. Other major organs (liver, kidney, blood system, etc.) are functioning normally: 1)Hemoglobin ≥ 9.0 g/dL (or can be maintained through blood transfusion or exceed this standard) 2)Red blood cell count ≥ 2.0 × 10\^9/L 3)Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L 4)Platelet count ≥ 100 × 10\^9/L 5)Total bilirubin is within the normal range 6)Alanine transaminase, aspartate transaminase, and alkaline phosphatase ≤ 2.5 times the upper limit of normal values 7)Creatinine ≤ 2.0 mg/dL; Creatinine clearance rate ≥ 60ml/min 8)The international normalized ratio (INR) of prothrombin time to activated partial thromboplastin time for patients who have not received anticoagulant therapy is ≤ 1.5 times the upper limit of normal. Patients who have received comprehensive or intravenous anticoagulant therapy can only participate in clinical trials if the dosage of anticoagulant drugs is stable for more than 2 weeks and the coagulation test results are within the local treatment range. 8\. ECOG PS score is 0-1 9. Women of childbearing age must undergo a pregnancy test within 7 days before treatment, and the result is negative. During the trial period and within 30 days after the end of the trial, reliable contraceptive measures such as intrauterine devices, birth control pills, condoms, etc. should be taken. During the trial period and within 30 days after the end of the trial, men of childbearing age should use condoms for contraception; 10. Patients should sign an informed consent form Exclusion Criteria: 1. The patient has received systemic anti-cancer treatment for non-small cell lung cancer, including surgical treatment, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, etc 2. Patients with other cancers (excluding cervical cancer in situ, cured basal cell carcinoma, and bladder epithelial tumors \[including Ta and Tis\]) within the 5 years prior to the trial, unless they have small cell lung cancer 3. The patient has any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, angina that has started to occur in the past 3 months, congestive heart failure \[≥ NYHA Grade II\], myocardial infarction (6 months prior to enrollment), severe arrhythmia, and liver, kidney, or metabolic diseases that require medication treatment) 4. The patient is an active hepatitis B, hepatitis C or HIV carrier 5. Severe or newly diagnosed gastrointestinal disease patients with diarrhea as the main symptom 6. The patient is receiving treatment with P-glycoprotein inhibitors 7. Individuals who have previously suffered or are currently suffering from cardiovascular malformations 8. The patient has previously suffered from or is currently suffering from interstitial lung disease 9. The patient has undergone other major systemic surgeries or suffered severe trauma within the 3 months prior to the trial 10. Suffering from neurological or psychiatric disorders 11. The patient has malabsorption 12. Female patients in pregnancy or lactation period 13. Other researchers believe that patients are not suitable for inclusion in the study
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for EGFR are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Hubei Cancer Hospital
Wuhan, Hubei, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Phase ib clinical study of toripalimab combined with gemcitabine and cisplatin neoadjuvant chemotherapy in patients with resectable locally advanced head and neck squamous cell carcinoma
- Can a targeted pill after surgery keep early lung cancer from returning?
- Can a targeted pill clear hidden lung cancer cells after surgery?
- MRI 'Fingerprint' may reveal which head and neck tumors vanish with Pre-Surgery therapy
- Can a Two-Drug punch shrink esophageal tumors before surgery?
- Can a Dual-Drug combo shrink lung tumors before surgery?