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A Multicenter Phase II Randomized Trial of Limertinib Followed by Sintilimab and Chemotherapy vs. Limertinib Followed by Limertinib and Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIB EGFR-Mutant NSCLC

ConditionResectable Non-small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWen-zhao ZHONG

About this trial

This clinical trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Limertinib Followed by Sintilimab and Chemotherapy in resectable Stage II-IIIB EGFR-Mutant NSCLC. Untreated stage II-IIIB NSCLC (AJCC 8th edition) patients assessed as surgically resectable by investigators will be randomized 1:1 into the experimental or control group after signing informed consent and meeting eligibility criteria. All patients receive Limertinib for 6 weeks. Within 7 days thereafter, imaging assessment will be performed. If no progression is observed, experimental group patients discontinue therapy for 1 week, then receive Sintilimab + Carboplatin/Cisplatin + Pemetrexed every 3 weeks for 3 cycles; control group patients receive Limertinib for 9 weeks and Carboplatin/Cisplatin + Pemetrexed every 3 weeks for 3 cycles. Preoperative tumor assessment is required. Surgery will be performed 2-6 weeks (±7 days) after the first dose of the final cycle. Then patients will recieve 2-year adjuvant Osimertinib starting 1 month post-surgery. If imaging assessment after 6 weeks of limertinib treatment shows lesion enlargement but remains confined to stage II-IIIB, the investigator will decide whether the patient continues study treatment or not; if progression occurs to unresectable stage III or advanced disease, the patient must discontinue. The primary endpoint is pathological complete response (pCR) rate.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed written informed consent form

Age: 18-75 years.

Cytologically/histologically confirmed (via percutaneous lung puncture, bronchoscopy, mediastinoscopy, etc.), previously untreated stage II-IIIB (IASLC 8th Edition Thoracic Tumor Classification) lung adenocarcinoma.

Tumor tissue or blood samples confirmed as EGFR-sensitive or rare mutation-positive by laboratory testing

Disqualifiers

Patients with stage I or IV NSCLC who have previously received systemic anti-tumor therapies (e.g., ICIs, targeted therapy, chemotherapy).

Active known or suspected autoimmune diseases (exceptions: type I diabetes, hypothyroidism requiring hormone replacement only, non-progressive skin conditions like vitiligo/psoriasis/alopecia).

Active hepatitis B (HBsAg-positive) or hepatitis C (HCV RNA-positive). Patients with resolved HBV infection (HBsAg-negative, HBcAb-positive) must provide HBV DNA-negative results. HCV antibody-positive patients require negative HCV RNA PCR.

HIV-positive or AIDS history.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Limertinib+sintilimab+chemotherapy

    Drug

    Experimental group patients receive Limertinib for 6 weeks. Within 7 days thereafter, imaging assessment will be performed. If no progression is observed, experimental group patients discontinue therapy for 1 week, then receive Sintilimab + Carboplatin/Cisplatin + Pemetrexed every 3 weeks for 3 cycles.

  • Limertinib+chemotherapy

    Drug

    Control group group patients receive Limertinib for 6 weeks. Within 7 days thereafter, imaging assessment will be performed. If no progression is observed, control group patients receive Lilotinib for next 9 weeks + Carboplatin/Cisplatin + Pemetrexed every 3 weeks for 3 cycles.

  • surgery

    Procedure/Surgery

    The surgical procedure may involve minimally invasive surgery (video-assisted thoracoscopic surgery, robot-assisted surgery) or open thoracotomy. The surgical methods include lobectomy, combined lobectomy, pneumonectomy, sleeve resection, and ipsilateral systematic mediastinal lymph node dissection (for left-sided tumors, stations 4L, 5, 6, 7, and 9 should be included; for right-sided tumors, at least stations 2R, 3A, 4R, 7, and 9 should be included).

  • Osimertinib

    Drug

    Adjuvant treatment with Osimertinib for 2 years

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 3 interventions
Group B: Control GroupActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Pathologic Complete Response Rate

Pathology evaluation confirmed no residual tumor cells in the resected specimen and regional lymph nodes.

Time frame
Up to approximately 6 weeks following completion of surgery

Secondary outcomes

1

Major Pathological Response (mPR) Rat

mPR rate is defined as ≤ 10% residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.

Time frame
Up to approximately 6 weeks following completion of surgery
2

Event Free Survival (EFS)

EFS is defined as the time from randomization to the first recorded time to any first documented progression, recurrence or death, which occurs first.

Time frame
Up to approximately 2.5 years following the beginning of Post-operative Assessment baseline
3

Disease free survival (DFS)

DFS is defined as the time from surgery to disease recurrence or death due to any cause.

Time frame
Up to approximately 2 years following the begining of Post-operative Assessment baseline
4

Overall survival (OS)

OS is defined as the time from randomization to death due to any cause.

Time frame
Up to approximately 2.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wen-zhao ZHONG

Lead sponsor

Guangdong Provincial People's Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: