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NCT07038460: NEO-LISI
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
Phase 2 trial testing Limertinib+sintilimab+chemotherapy in Resectable Non-small Cell Lung Cancer in 134 participants. Not yet recruiting.
1 December 2027
Quick facts
| Lead sponsor | Wen-zhao ZHONG |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 134 |
| Start date | 1 July 2025 |
| Primary completion | 1 December 2027 |
| Estimated completion | 1 December 2029 |
| Sites | 6 locations across China |
Drugs / interventions tested
- Limertinib+sintilimab+chemotherapy — full drug profile →
- Limertinib+chemotherapy — full drug profile →
- surgery
- Osimertinib (osimertinib) — full drug profile →
Conditions studied
- Resectable Non-small Cell Lung Cancer — all drugs for Resectable Non-small Cell Lung Cancer →
Sponsor
Wen-zhao ZHONG — full company profile →
Who can join
Adults 18 to 75, any sex, with Resectable Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Pathologic Complete Response Rate
Time frame: Up to approximately 6 weeks following completion of surgery
Pathology evaluation confirmed no residual tumor cells in the resected specimen and regional lymph nodes.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07038460
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Resectable Non-small Cell Lung Cancer
Currently open trials in the same condition.
- NCT06161441 — A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combina · Phase 2 · active not recruiting
- NCT06169956 — An Observational Study to Evaluate Neoadjuvant Nivolumab (OPDIVO®) in Combination With Platinum-Based Chemotherapy in No · recruiting
- NCT05247684 — AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC · Phase 2 · active not recruiting
Other Wen-zhao ZHONG trials
Trials by the same sponsor.
- NCT07039656 — Toripalimab Combined With Chemotherapy as Adjuvant Therapy for Non-small Cell Lung Cancer With or Without Prior Neoadjuv · Phase 2 · recruiting
- NCT04552054 — Mixed Reality Technique Combined With 3D Printing Navigational Template for Localizing Pulmonary Nodules · NA · unknown
- NCT04056923 — 3D Printing for Nodule Localization · NA · completed
- NCT03230019 — Two-Lumen Catheterization For Lung Wedge Resection · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07038460 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wen-zhao ZHONG
- Last refreshed: 18 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07038460.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing