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NCT Number: NCT05377658

AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer

AK104, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of AK104 with chemotherapy as neoadjuvant and adjuvant therapy for patients with resectable stage II-IIIA NSCLC.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location status: Recruiting

Location contact

Huijuan Wang, MD

CONTACT

[email protected]

18638561588

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Have previously untreated and pathologically confirmed resectable Stage II-IIIA NSCLC.
  • Have at least one measurable lesion per RECIST 1.1 assessed by investigator.
  • Have adequate organ function.

Key Exclusion Criteria:

  • Mixed NSCLC and small cell lung cancer histology.
  • Patients with other active malignancies within 3 years prior to enrollment.
  • Known active autoimmune diseases.
  • Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.
  • Presence of other uncontrolled serious medical conditions.

Treatment and study plan

AK104

Drug

10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.

Other names: Cadonilimab

Albumin-bound paclitaxel

Drug

260mg/m^2 via intravenous infusion on Day 1 of each 21-day cycle.

carboplatin

Drug

AUC 5 mg/mL/min via intravenous infusion on Day 1 of each 21-day cycle.

Primary outcomes

  1. Pathological Complete Response (pCR) Rate

    Time frame: At time of surgery

    defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.

Secondary outcomes

  1. Major Pathological Response (MPR) Rate

    Time frame: At time of surgery

    defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.

  2. Incidence of Surgical Complications

    Time frame: Up to approximately 30 days following surgery

    defined as ≥ grade 3 or severe intraoperative and perioperative complications.

  3. Complete (R0) Resection Rate

    Time frame: After surgery (approximately 7 weeks)

    defined as the percentage of participants achieving complete surgical resection following completion of neoadjuvant therapy.

  4. Objective Response Rate (ORR)

    Time frame: At the end of 3 cycles of neoadjuvant therapy (each cycle is 21 days)

    defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.

  5. Event Free Survival (EFS)

    Time frame: Up to approximately 5 years

    defined as the time from the first dose of study drug to disease progression per RECIST 1.1 that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first.

  6. Adverse Events (AEs)

    Time frame: From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Huijuan Wang, MD

CONTACT

[email protected]

18638561588

Sponsors and collaborators

Lead sponsor

Henan Cancer Hospital

Other Gov

Registry information

Official study title

A Single-Arm, Phase II Study of AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
May 17, 2022
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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