This is a single-arm, multicenter Phase II clinical study designed to observe and evaluate the efficacy and safety of Iparomlimab and tuvonralimab plus chemotherapy in initially unresectable Stage III NSCLC. The study plans to enroll 69 Stage III NSCLC patients judged unresectable by a MDT team, with the R0 resection rate as the primary endpoint.
After completing 2-4 cycles of conversion therapy, the MDT team reassesses resectability. Subjects deemed suitable for surgical resection undergo surgery within 6 weeks after the last dose of conversion therapy. Subjects deemed unsuitable for surgery receive radical chemoradiotherapy, starting within 6 weeks after the last conversion therapy dose. Subjects unsuitable for both surgery and chemoradiotherapy will have their subsequent treatment decided by the project team.
Adjuvant therapy consists of Iparomlimab and tuvonralimab monotherapy (Q3W) for up to 16 cycles.
Signed an informed consent form
Patients aged ≥18
Ipsilateral multi-station or confluent mediastinal lymph node metastasis: Imaging shows ipsilateral multi-station lymph node metastasis or confluent lymph node mass (>3cm diameter) or invasion of surrounding organs, making complete surgical clearance impossible.
Contralateral or supraclavicular lymph node metastasis (N3): This includes contralateral hilar and mediastinal lymph node metastasis, or ipsilateral/contralateral supraclavicular lymph node metastasis.
NSCLC with small cell component identified on pathology (regardless of proportion); Histological types of large cell neuroendocrine carcinoma, sarcomatoid carcinoma, or NSCLC-NOS.
Known EGFR mutation or ALK rearrangement positivity (eligibility of subjects with other driver gene positivity will be determined by the project biomarker expert group).
Prior systemic anti-tumor therapy or thoracic radiotherapy.
Single group
Iparomlimab and tuvonralimab plus chemotherapy
DrugSquamous Cell Carcinoma: 2-4 cycles of Iparomlimab and tuvonralimab 5mg/kg Q3W (Day 1) + Albumin-bound Paclitaxel (100mg/m² Q3W D1/D8/D15 or130mg/m²D1/D8 or 260mg/m²D1) + Carboplatin (AUC=5) Q3W (D1) Non-Squamous Cell Carcinoma: 2-4 cycles of Iparomlimab and tuvonralimab 5mg/kg Q3W (D1) + Pemetrexed 500mg/m² Q3W (D1) + Carboplatin (AUC=5) Q3W (D1) Radical Chemoradiotherapy for Patients Unable to Undergo Surgery:Patients still unresectable after conversion therapy should start radical chemoradiotherapy within 6 weeks after the last conversion therapy dose. Chemoradiotherapy follows standard clinical practice, recommended as Cisplatin 30mg/m² QW (D1) + 60Gy radiotherapy. Adjuvant Therapy Phase:Iparomlimab and tuvonralimab 5mg/kg Q3W (D1) for up to 16 cycles.
R0 Resection Rate
The proportion of patients who achieve complete tumor removal with no residual cancer cells at the surgical margin under microscopic examination after surgery
2-year event-free survival (EFS) rate
The percentage of patients who remain free of disease progression, recurrence, or death within 24 months from the initiation of therapy
Pathologic Complete Response (pCR)
Pathologic complete response (pCR) rate is defined as the percentage of patients with no residual viable tumor cells in both primary tumor and sampled lymph nodes after neoadjuvant therapy
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Chang Chen
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
