Low Dose Radiotherapy Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Stage II-III NSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnhui Provincial Cancer Hospital
About this trial
To evaluate efficacy and safety of low dose radiotherapy combined with sintilimab and platinum based chemotherapy as neoadjuvant therapy for stage II-III Non-Small Cell Lung Cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Sign a written Informed Consent Form (ICF) and be able to comply with the visit and related procedures specified in the protocol.
Age ≥ 18 years old.
Primary non-small cell lung cancer (including adenocarcinoma and squamous cell carcinoma) diagnosed by cytology or histology.
According to the International Association for the Study of Lung Cancer and the Joint Committee on Cancer Classification 8th edition (AJCC8) TNM staging classification of lung cancer, the clinical staging is IIB (primary tumor>4cm), IIIA, or IIIB (resectable N2 only) stage. Resectable N2 refers to non bulk (defined as a short diameter less than 3cm), discrete, or single site N2 involvement. If clinically suspected as N2 or N3, pathological confirmation is required.
Disqualifiers
1. Histological and pathological examinations show the presence of coexisting small cell carcinoma, large cell neuroendocrine tumor, and sarcomatoid tumor components.
Active infection (requiring treatment with anti infective drugs or having used systemic anti infective drugs within the week prior to randomization);
Congestive heart failure [New York Heart Association (NYHA) classification ≥ II]; Serious arrhythmias, liver, kidney or metabolic diseases that require medication treatment;
Untreated coronary atherosclerotic heart disease; Type I or II respiratory failure; History of gastrointestinal perforation and/or fistula, intestinal obstruction, extensive intestinal resection, or long-term chronic diarrhea within the past 6 months.
Trial design
Design model
Parallel
Treatments tested in this trial
Experimental
RadiationRadiation: 30Gy/15F Drug: Sintilimab, 200mg IV D1 Q3W Drug: Cisplatin, 75mg/m2 D1 IV Q3W or Carboplatin AUC 5-6mg/ml/min D1 IV Q3W Drug: Pemetrexed, 500mg/m2 D1 IV Q3W or Albumin paclitaxel 260mg/m2，D1 or 130mg/m2，D1,8 IV Q3W
Active comparator
DrugDrug: Sintilimab, 200mg IV D1 Q3W Drug: Cisplatin, 75mg/m2 D1 IV Q3W or Carboplatin AUC 5-6mg/ml/min D1 IV Q3W Drug: Pemetrexed, 500mg/m2 D1 IV Q3W or Albumin paclitaxel 260mg/m2，D1 or 130mg/m2，D1,8 IV Q3W
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: Low Dose Radiotherapy combined with Sintilimab and ChemotherapyExperimental treatment 1 intervention
Group B: Sintilimab in combination with ChemotherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pathologic Complete Response（pCR） rate
Pathological complete response (pCR) rate is defined as the proportion of participants whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.
Time frame
up to 8 weeks after surgerySecondary outcomes
1
Major pathological response (MPR) rate
Major pathological response (MPR) rate is defined as the proportion of participants whose percentage of residual tumor in the stomach and lymph node decreased to \< 10%, as determined by a pathologist.
Time frame
up to 8 weeks after surgery2
Objective Response Rate （ORR）
An objective response is defined as either a confirmed CR or a PR, as determined by the investigator using RECIST v1.1Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI).
Time frame
through study completion, an average of 1 year3
Event Free Survival（EFS）
proportion of participants who have no events，including death, disease progression, change of chemotherapy regimen, switching to chemotherapy, addition of other treatments, occurrence of lethal or intolerable side effects, etc
Time frame
up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov