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NCT06591910Not yet recruiting

Induction Therapy With Serplulimab Combined With Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer

Induction Therapy With Serplulimab Combined With Chemotherapy Followed by Local Therapy for Unresectable Stage III Non-small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

For unresectable stage III (8th TNM) non-small cell lung cancer, chemoradiotherpay plus immunotherapy is recommended by PACIFIC trial. However, it is unclear whether induction chemoimmunotherapy followed by surgery or radiotherapy can provide good survival for this population. This prospective observational study aims to investigate the efficacy and safety of the therapeutic regimen of chemoimmunotherapy plus surgery/radiotherapy.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
50 (estimated)
First submitted
8 Sept 2024
Start date
20 Sept 2024
Primary completion date
20 Sept 2026
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Diseases
Lung cancer
NCT number
NCT06591910

What you commit to

  • Study type: Observational
  • Planned participants: 50
  • From 20 Sept 2024 to the primary completion date, 20 Sept 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
  • Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;

Other illness

  • With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
  • Participants who are allergic to the test drug or any auxiliary materials;
  • Participants with Interstitial lung disease currently;
  • Participants with active hepatitis B, hepatitis C or HIV;
  • Participants suffering from nervous system diseases or mental diseases that cannot cooperate;

Other

  • Pregnant or lactating women;
  • Participated in another therapeutic clinical study;
  • Other factors that researchers think it is not suitable for enrollment.

Who the study is looking for

  • The patient shall sign the Informed Consent Form.
  • Aged 18 ≥ years.
  • Histological or cytological diagnosis of unresectable NSCLC by needle biopsy, and stage III (8th TNM) confirmed by imageological examinations (CT, PET-CT or EBUS).
  • Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
  • Life expectancy is at least 12 weeks.
  • At least 1 measurable lesion according to RECIST 1.1.
  • Patients with good function of other main organs (liver, kidney, blood system, etc.)
  • Patients with normal lung function can tolerate surgery;
  • Without systematic metastasis (including M1a, M1b and M1c);
  • Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
  • Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.