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Recruiting NCT05940532

A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC

Phase II Interventional Carcinoma, Non-Small-Cell Lung

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sugemalimab and Chemotherapy.
Who it may be relevant to
Registry conditions: Carcinoma, Non-Small-Cell Lung. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-arm Phase 2 Study of Sugemalimab and Chemotherapy as Induction Therapy in Unresectable and Stage III Non-small Cell Lung Cancer (NSCLC)

Overview

The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer.

Interventions

  • Drug Sugemalimab and Chemotherapy
    Chemotherapy: Paclitaxel 175mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for NSCLC; Pemetrexed 500mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for non-squamous NSCLC; intravenous infusion every 3 weeks, for up to four cycles. Sugemalimab: 1200 mg by intravenous infusion every 3 weeks, for up to 2 years.

Primary outcome measures

  • ORR [Time frame: From the initiation of the first dose to 3 years]
Secondary outcome measures (7)
  • PFS [Time frame: From the initiation of the first dose to 3 years]
  • OS [Time frame: From the initiation of the first dose to 3 years]
  • iORR [Time frame: From the initiation of the first dose to 3 years]
  • AEs [Time frame: From the initiation of the first dose to 90 days after the last dose]
  • Measurement of Quality of Life with EORTC QLQ-C30 questionnaire [Time frame: From the initiation of the first dose to 3 years]
  • Measurement of Quality of Life with EORTC QLQ-LC13 questionnaire [Time frame: From the initiation of the first dose to 3 years]
  • Measurement of Quality of Life with EORTC EQ-5D-5L VAS questionnaire [Time frame: From the initiation of the first dose to 3 years]

Eligibility criteria

Inclusion criteria

1.18 to 75 years old, both male and female;

2.ECOG score: 0-1;

3.Histopathologically or cytologically confirmed, stage III (AJCC 8th) non-small cell lung cancer;

4.Multidisciplinary team (MDT) discussion confirmed unresectable disease but can be treated by curative radiotherapy;

5.Measurable lesions available;

6.Major organ function is basically normal;

7.Estimated survival time is at least 6 months;

8.Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before inclusion.

Exclusion criteria

  • Histologically or cytologically confirmed mixed SCLC and NSCLC;
  • Subjects with driver gene mutations(EGFR mutation, ALK fusion, etc.);
  • Previous systemic anti-tumor therapy including immune checkpoint inhibitors for NSCLC;
  • Previous thoracic radiotherapy;
  • Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose;
  • Systemic immunostimulant therapy before the first dose;
  • Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment;
  • Subjects with autoimmune diseases;
  • Other malignant tumors other than non-small cell lung cancer within 5 years before screening;
  • Known or suspected interstitial pneumonia;
  • Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function;
  • Severe cardiovascular and cerebrovascular diseases;
  • Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose;
  • Arteriovenous thrombotic events within 3 months before the first dose;
  • Positive HIV test;
  • Active hepatitis B or C;
  • Evidence of active tuberculosis infection within 1 year before the first dose;
  • Serious infection within 4 weeks before the first dose;
  • History of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study;
  • Major surgeries other than diagnosis or biopsy within 28 days prior to the first dose;
  • Previous or planned allogeneic bone marrow transplantation or solid organ transplantation;
  • History of severe allergic reactions to other monoclonal antibodies/fusion proteins;
  • Allergic to any component of the randomized treatment regimen;
  • Female subjects who are pregnant, lactating, or planning to get pregnant during the study period;
  • Subjects who have a known history of psychotropic drug abuse, alcoholism, or drug abuse;
  • Presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Hunan Cancer Hospital — Changsha

Identifiers

NCT: NCT05940532 · HTOSG Lung 001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗