A Single-arm, Multicenter, Prospective Clinical Study of Adebrelimab Combined With Apatinib Neoadjuvant Therapy for Resectable Non-small Cell Lung Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital of Xiamen University

About this trial

To evaluate the major pathological response rate of Adibelimab combined with Apatinib neoadjuvant therapy in resectable non-small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years old ≤ age ≤70 years old, male or female;

ECOG PS score 0-1;

Patients who have not received systematic treatment before and agree to receive radical surgical treatment; Thoracic surgeons judge patients with no contraindications to surgery;

Stage II, IIIA, or selective stage IIIB (T3N2M0 only) squamous cell or non-squamous non-small cell lung cancer confirmed by histopathology or cytology and determined by the investigator to be capable of R0 resection for curative purposes. Staging should be based on the American Joint Committee on Cancer (AJCC)/Union International Against Cancer (UICC) NSCLC Staging System Version 8;

Disqualifiers

have received any anti-tumor therapy in the past, including radiotherapy, chemotherapy, immunotherapy and traditional Chinese medicine anti-tumor therapy (except the treatment of malignant tumors with radical treatment and no recurrence and metastasis for more than 5 years);

Subjects with non-squamous cell histological types of NSCLC with EGFR mutation positive or ALK positive. Non-squamous cell carcinoma subjects must undergo EGFR gene testing and ALK gene and/or immunohistochemical testing;

Patients with distant metastases (including M1a, M1b, and M1c);

Have any active autoimmune disease or history of autoimmune disease (such as uveitis, enteritis, hepatitis, pituitaritis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy), tuberculosis); Skin conditions (such as vitiligo, psoriasis, or alopecia) with complete remission of childhood asthma that do not require any intervention in adulthood and do not require systemic treatment may be included, but patients requiring medical intervention with bronchodilators may not be included;

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab

    Drug

    Adebrelimab 1200mg, iv, D1,Q3W

  • Apatinib

    Drug

    Apatinib 250mg,P.O,qd,Q3W

Treatment groups

43 Participants
are divided into 1 treatment group
Group A: Adebrelimab in combination ApatinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Major pathological response (MPR)

When the tumor was surgically resected, the active tumor tissue in the surgical specimen was less than 10%

Time frame
Four weeks after surgery

Secondary outcomes

1

Pathological complete response (pCR)

Time frame
Four weeks after surgery
2

R0 resection rate

Time frame
Four weeks after surgery
3

Objective response rate (ORR)

Time frame
Up to 3 months per 2 cycles (21 days per cycle)
4

The incidence of adverse events (including serious adverse events) and rank

Time frame
Up to 24 weeks

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: