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A Study of Adebrelimab in Combination with Chemo with or Without Bevacizumab Neoadjuvant Therapy for Resectable NSCLC

ConditionResectable Lung Non-Small Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe First Affiliated Hospital of Guangzhou Medical University

About this trial

This is a prospective, multicenter, randomized, uncontrolled Phase II study to assess the efficacy and safety of adebrelimab in combination with chemotherapy with or without bevacizumab for the treatment of resectable Stage II-IIIB (T3N2) NSQ-NSCLC and to explore biomarkers associated with efficacy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Resectable NSQ NSCLC

Age 18-65 years

male or female

ECOG 0-1

Disqualifiers

SCLC or SQ NSCLC

previously used anti-PD1, anti-PDL1, anti-CTLA4 antibodies, etc.

patients who have previously used anti-angiogenic drugs;

allergic to any component of the study drug or chemotherapy drugs

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adebellizumab

    Drug

    adebrelimab

  • Bevacizumab

    Drug

    bevacizumab

  • Platinum-based chemotherapy

    Drug

    paclitaxel or albuminotaxol or docetaxel combined with platinum, pemetrexed combined with platinum. Platinums include carboplatin, cisplatin and nedaplatin.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: four-drug combination groupExperimental treatment 3 interventions
Group B: three-drug combination groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response

Pathological complete response, pCR (primary tumor + lymph nodes).It refers to the proportion of subjects with no residual surviving tumor cells (including lymph nodes) in the postoperative specimen among the enrolled subjects

Time frame
After 4 cycles of neoadjuvant therapy(3 weeks per cycle), surgical resection was performed at intervals of 4-6 weeks. Pathological response assessment results were assessed within one week after surgery.

Secondary outcomes

1

Major Pathological response

It refers to the proportion of subjects with residual surviving tumor cells of ≤ 10% in the postoperative specimen among the enrolled subjects.

Time frame
After 4 cycles of neoadjuvant therapy(3 weeks per cycle), surgical resection was performed at intervals of 4-6 weeks. Pathological response assessment results were assessed within one week after surgery.
2

Overall response rate

It refers to the proportion of patients whose tumor shrinks to a certain extent and maintains it for a certain period of time, including CR and PR cases.

Time frame
After 4 cycles of neoadjuvant therapy(3 weeks per cycle), before surgical resection was performed（at intervals of 4-6 weeks）.
3

event free survival

Defined as disease progression from randomization to imaging confirmation, local progression leading to inoperable tumors, unresectable tumors, local or distant recurrence, and death from any cause.

Time frame
from randomization to imaging confirmation, local progression leading to inoperable tumors, unresectable tumors, local or distant recurrence, and death from any cause, whichever came first, assessed up to 24 months.
4

safety

Monitoring and recording of adverse events, including Incidence of serious adverse events and adverse events of special interest.

Time frame
Safety follow-up will be conducted 30 ± 7 days after the last use of bevacizumab/chemotherapy or 90 ± 7 days after the last use of adebrelimab/surgery (whichever occurs later) to track the relief of AE. Incidence of AE/SAE/TRAE will be recorded.

Other outcomes

Sponsors and contacts

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

The First Affiliated Hospital of Guangzhou Medical University

Lead sponsor

Source ClinicalTrials.gov
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