This is a Two-cohort, Exploratory Clinical Study Assessing the Activity of Benmelstobart Combined With Chemotherapy With or Without Anlotinib in Resectable Limited-Stage Small Cell Lung Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTang-Du Hospital

About this trial

A total of 66 patients were enrolled in this exploratory study and randomly assigned to cohort 1 and cohort 2, with 33 patients in each group. Cohort 1: Neoadjuvant therapy (benmelstobart combined with chemotherapy and anlotinib, 3 cycles, every 21 days is a cycle). 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. Patients who achieved R0 resection received adjuvant therapy (benmelstobart combined with anlotinib, 12 cycles, every 21 days is a cycle). Cohort 2: Neoadjuvant therapy (benmelstobart combined with chemotherapy, 3 cycles, every 21 days is a cycle). 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. Patients who achieved R0 resection received adjuvant therapy (benmelstobart, every 21 days is a cycle) .

Eligibility criteria

Qualifiers

Patients voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.

Aged 18 to 75 years (inclusive) at the time of signing informed consent, regardless of gender.

Histologically confirmed small cell lung cancer (SCLC).

Confirmed as stage I-IIIB SCLC (T1-3N0-2M0) per AJCC 9th Edition.

Disqualifiers

Histologically confirmed mixed-type SCLC.

Extensive-stage SCLC.

ECOG PS >1.

Active or untreated CNS metastases confirmed by CT/MRI during screening/prior imaging.

Trial design

Treatments tested in this trial

  • benmelstobart combined with chemotherapy and anlotinib
  • benmelstobart combined with chemotherapy

Treatment groups

66 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators