A Phase II Randomized Trial of Neoadjuvant Ivonescimab or Penpulimab Plus Chemotherapy in Resectable NSCLC

ConditionsNSCLC Neoadjuvant Therapy Immunotherapy AK112 Bispecific Antibody

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorYang Fan, MD

About this trial

This is a randomized, open-label, multicenter phase II study. The trial plans to enroll 164 subjects with resectable stage IIA-IIIB (N2) NSCLC. Participants will be randomized 1:1 into either the ivonescimab plus chemotherapy or penpulimab plus chemotherapy treatment arm. After 3-4 cycles of neoadjuvant therapy, surgical resection will be performed. The primary objective is to compare the pathological complete response (pCR) rate assessed by local pathologists between ivonescimab-based and penpulimab-based chemo-immunotherapy regimens in the neoadjuvant treatment of resectable NSCLC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign the written Informed Consent Form (ICF) and consent to receive curative surgical treatment.

Participants must be aged ≥ 18 years, regardless of gender.

Eastern Cooperative Oncology Group (ECOG) Performance Status Score is 0-1.

Histologically confirmed resectable Stage IIA-IIIB (N2) non-small cell lung cancer (NSCLC) according to the 9th edition of the TNM staging system for lung cancer by the Union for International Cancer Control (UICC) and the American Joint Committee on Cancer (AJCC).

Disqualifiers

Patients with large cell neuroendocrine carcinoma (LCNEC) or NSCLC mixed with small cell lung cancer components;

Presence of locally advanced unresectable disease (any stage) or metastatic disease (Stage IV). Subjects with contralateral mediastinal lymph node involvement confirmed by PET-CT scan.

NSCLC diagnosed with EGFR-sensitive mutations or ALK gene translocation. For non-squamous cell carcinoma subjects (including NSCLC with unclear pathology), tumor tissue-based EGFR and ALK testing results must be provided. If EGFR/ALK status is unknown, testing must be performed prior to enrollment. For squamous NSCLC subjects, EGFR/ALK testing is not required during screening if status is unknown.

Any prior systemic or local anti-tumor therapy for NSCLC;

Trial design

Design model

Parallel

Treatments tested in this trial

Ivonescimab+Chemo
Drug
Ivonescimab (AK112) + platinum-based doublet chemotherapy
Penpulimab+Chemo
Drug
Penpulimab (AK105) + platinum-based doublet chemotherapy

Treatment groups

164 Participants

are divided into 2 treatment groups

Group A: Ivonescimab+ChemoExperimental treatment 1 intervention

Group B: Penpulimab+ChemoActive comparator 1 intervention

Trial outcomes

Primary outcomes

Pathologic Complete Response (pCR) Rate

Pathologic complete response (pCR) rate is defined as the percentage of participants with no residual viable tumor in lung primary or lymph nodes as evaluated by systematic pathological review of surgical specimens.

Time frame

Within 1 month after surgery

Secondary outcomes

Major Pathologic Response (MPR) Rate

Major pathologic response (MPR) rate is defined as the percentage of participants with less than 10% of residual viable tumor in lung primary or lymph nodes as evaluated by systematic pathological review of surgical specimens. Viable tumors in situ carcinoma should not be included in MPR calculation.

Time frame

Within 1 month after surgery

Event-Free Survival (EFS)

Defined as the time from the first dose to the occurrence of any of the following events (whichever occurs first), assessed in the Intention-To-Treat (ITT) population: Disease progression (based on RECIST v1.1 criteria by investigators); Local recurrence or distant metastasis; Death from any cause

Time frame

the time from the first dose to the occurrence of any of the following events (whichever occurs first), assessed in the Intention-To-Treat (ITT) population: Disease progression (based on RECIST v1.1 criteria by investigators); Local recurrence or dist

Other outcomes

Deep pathologic response (DPR) rate

Deep pathologic response (DPR) rate is defined as the percentage of participants with less than 5% of residual viable tumor in lung primary or lymph nodes as evaluated by systematic pathological review of surgical specimens. Viable tumors in situ carcinoma should not be included in DPR calculation.

Time frame

Within 1 month after surgery

Objective response rate（ORR）

Preoperative radiological evaluation (as assessed by the investigator according to RECIST v1.1) of the number of complete or partial responses as a proportion of the population in the cohort.

Time frame

Within 1 month after surgery

Overall Survival (OS)

Defined as the time from the date of randomization to the date of death due to any cause in the Intention-To-Treat (ITT) population.

Time frame

The time from the date of randomization to the date of death due to any cause

2-Year/3-year EFS rate

Defined as the proportion of patients without EFS events at 2 and 3 years after randomization estimated using the Kaplan-Meier method

Time frame

At 2 and 3 years after randomization

Sponsors and contacts

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

Yang Fan, MD

Lead sponsor

Peking University People's Hospital

Sponsor institution

Source ClinicalTrials.gov

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