Can a Triple-Drug combo before surgery eliminate EGFR-Mutant lung cancer?

NCT ID NCT07807722

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

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