NCT06851169

This is a Two-cohort, Exploratory Clinical Study Assessing the Activity of Benmelstobart Alone or Combined with Anlotinib Administered Prior to Surgery in Terms of Pathological Complete Response

Not yet recruiting Phase 2 Last updated 28 February 2025

What this trial tests

Phase 2 trial testing Cohort 1: Neoadjuvant therapy (benmelstobart combined with anlotinib) in Non Small Cell Lung Cancer in 58 participants. Not yet recruiting.

Timeline

1 April 2025

Primary endpoint
1 February 2027

1 August 2027

Quick facts

Lead sponsor	Tang-Du Hospital
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	58
Start date	1 April 2025
Primary completion	1 February 2027
Estimated completion	1 August 2027

Drugs / interventions tested

• Cohort 1: Neoadjuvant therapy (benmelstobart combined with anlotinib) — full drug profile →
• Cohort 2: Neoadjuvant therapy (benmelstobart only) — full drug profile →

Conditions studied

• Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →

Sponsor

Tang-Du Hospital

Who can join

Adults 18 to 75, any sex, with Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A total of 58 patients were enrolled in this exploratory study and randomly assigned to cohort 1 and cohort 2, with 29 patients in each group. Cohort 1: Neoadjuvant therapy (benmelstobart combined with anlotinib, 3 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1; anlotinib, 12 mg, po, qd, was taken orally for 2 consecutive weeks and stopped for 1 week. Anlotinib was stopped 1 week before surgery. Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Adjuvant therapy (benmelstobart combined with anlotinib, 12 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1; anlotinib, 12 mg, po, qd, was taken orally for 2 weeks and stopped for 1 week. Cohort 2: Neoadjuvant therapy (benmelstobart only, 3 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1. Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Adjuvant therapy (benmelstobart, 12 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Benmelstobart+anlotinib: an emerging therapeutic option in the targeted-immunotherapy era.
   Cheng P, Gu H, Chen Q, Zhao G, et al · · 2026 · PMID 42052493 · DOI 10.3389/fonc.2026.1748214