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NCT06837948
Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Monoclonal Antibody in Locally Advanced NSCLC
Phase 2 trial testing PM8002 in Locally Advanced Non-Small Cell Lung Cancer in 160 participants. Not yet recruiting.
1 December 2031
Quick facts
| Lead sponsor | Shanghai Pulmonary Hospital, Shanghai, China |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 160 |
| Start date | 18 February 2025 |
| Primary completion | 1 December 2031 |
| Estimated completion | 1 December 2031 |
| Sites | 1 location across China |
Drugs / interventions tested
- PM8002 — full drug profile →
- Sintilimab — full drug profile →
- Nab-paclitaxel (nab-paclitaxel) — full drug profile →
- Carboplatin (Carboplatin) — full drug profile →
- Surgery
Conditions studied
- Locally Advanced Non-Small Cell Lung Cancer — all drugs for Locally Advanced Non-Small Cell Lung Cancer →
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Who can join
18 and older, any sex, with Locally Advanced Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Surgical intervention remains the primary treatment option for early-stage lung cancer. With the proven efficacy of immunotherapy in the treatment of advanced non-small cell lung cancer (NSCLC), neoadjuvant immunotherapy has increasingly become a focal point of research. Blocking vascular endothelial growth factor (VEGF) not only inhibits the proliferation of vascular endothelial cells and the formation of new blood vessels but also improves the tumor microenvironment and enhances the infiltration of cytotoxic T lymphocytes within it. Simultaneously targeting the VEGF and PD-L1 pathways can create a synergistic anti-cancer effect. PM8002 injection is a bispecific antibody drug that targets both PD-L1 and VEGF, functioning as a dual-action agent that combines immune suppression and anti-angiogenesis. In patients with locally advanced stage II-III NSCLC, neoadjuvant therapy that concurrently targets PD-L1/VEGF in combination with chemotherapy can improve pathological response rates, provided that the safety of the drug combination is maintained. This approach offers additional benefits to patients, prolongs event-free survival (EFS), and improves prognosis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06837948
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PM8002
Trials testing the same drug.
- NCT06616532 — PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer · Phase 3 · recruiting
- NCT05879055 — A Study of PM8002 in Combination With Chemotherapy in Patients With NEN · Phase 2 · recruiting
- NCT05918107 — A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM · Phase 2 · recruiting
- NCT05918133 — A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC · Phase 1, PHASE2 · active not recruiting
- NCT05879068 — A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC · Phase 2 · active not recruiting
Other recruiting trials for Locally Advanced Non-Small Cell Lung Cancer
Currently open trials in the same condition.
- NCT07309952 — Neoadjuvant SBRT Followed by Sintilimab Plus Chemotherapy for N3-Positive NSCLC · Phase 2 · recruiting
- NCT07052669 — Hypofractionated Versus Conventional Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced NSCLC · Phase 3 · recruiting
- NCT06734702 — Neoadjuvant Immunotherapy Plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Immunotherapy for · Phase 3 · recruiting
- NCT06755684 — Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR · Phase 2 · recruiting
- NCT07037680 — Radiotherapy Plus Anlotinib in LA-NSCLC Intolerable to cCRT · Phase 2 · recruiting
Other Shanghai Pulmonary Hospital, Shanghai, China trials
Trials by the same sponsor.
- NCT07469488 — A Clinical Trial on the Outcomes of Comprehensive Enhanced Prophylaxis Management (CEPM) in Chinese Patients With EGFR-M · Phase 4 · not yet recruiting
- NCT07494591 — TEAS for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery · NA · not yet recruiting
- NCT07517640 — Combining Furmonertinib With Local Therapy for Inoperable Early-stage Lung Cancer: A Phase II Trial · Phase 2 · not yet recruiting
- NCT07393438 — Acetohydroxamic Acid Combined With a Short-Course Regimen for MDR-TB (AHA-PLUS) · Phase 2 · not yet recruiting
- NCT07375979 — A Multi-modal Integrating Imaging and Cell-free DNA Methylation in Lung Cancer Early Detection (CMe-Lung): a Multi-cente · not yet recruiting
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 NCT06837948 (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 Shanghai Pulmonary Hospital, Shanghai, China
- Last refreshed: 20 February 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/NCT06837948.
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