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NCT05800340RecruitingPhase 2

Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC

Neoadjuvant Toripalimab Combined With Chemotherapy in Rare Mutations Stage IIB-IIIB NSCLC

Source: ClinicalTrials.gov · Last updated 5 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Phase II, single-arm, open-label single center study that assess clinical feasibility and safety of 3 cycles neoadjuvant Toripalimab plus chemotherapy in rare mutations stage IIB-IIIB NSCLC followed by optional adjuvant treatment upon investigators' decisions.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
30 (estimated)
First submitted
21 Mar 2023
Start date
4 Apr 2023
Primary completion date
31 Dec 2024
Lead sponsor
Guangdong Provincial People's Hospital
Diseases
Lung cancer
NCT number
NCT05800340

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 30
  • From 4 Apr 2023 to the primary completion date, 31 Dec 2024
  • 1 site in 1 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

  • Patients who have previously used any other anti-tumor drugs or radiotherapy;
  • A history of active bleeding within the 6 months before enrollment, or receiving thrombolysis or anticoagulant therapy, or the investigator believes that there is a clear tendency to gastrointestinal bleeding (such as esophageal varices with bleeding risk, local activity) Ulcer lesions, etc.) or active hemoptysis;
  • Patients with low compliance or willingness to take the drugs and surveillance.

Other illness

  • Histologically confirmed small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);
  • Patients with any underlying disease that investigators consider it may affect patient's prognosis including sever cardiovascular, pulmonary disease or serious infections; Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients with total gastrectomy;
  • Known or suspected autoimmune disease with activity. Participants may be enrolled if they have type 1 diabetes, hypothyroidism that requires only hormone replacement therapy, skin diseases that require no systemic treatment (such as purpura, psoriasis, or hair loss), or other conditions that are not expected to return without external trigger.
  • Patients with active hepatitis B (positive for HBsAg) or hepatitis C (positive for HCV RNA).
  • Patients with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
  • Patients with other active malignancies within five years

Lab values

  • Large panel NGS indicated sensitive EGFR alteration, ALK fusion, ROS1 fusion or any other driver mutations combined with MDM2/MDM4 amplification;

Other

  • Stage I and stage IV NSCLC;
  • Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures;

Who the study is looking for

  • Age: 18 Years and older
  • ECOG physical score 0-1 points; expected survival time ≥ 3 months;
  • Pathologically confirmed diagnosis with Stage IIB-IIIB NSCLC which harbored rare driver alteration including RET fusions, BRAF (V600E or non-V600E but confirmed driver mutations), ERBB2 exon20 insertion, MET amplification (FISH confirmed) or exon 14 skipping. Suspected N2 disease should be confirmed by either mediastinoscopy or EBUS. N1 disease could be determined through PET/CT but biopsy of primary lung cancer is needed;
  • Lung function capacity capable of tolerating the proposed lung surgery
  • Available tissue of tumor for PD-L1 test
  • Subjects voluntarily joined the study and signed informed consent, with good compliance to follow-up.

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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
Coordinator of this site? Confirm its status
GuanzhouChinaRecruiting

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