NCT05503667RecruitingPhase 2
Neoadjuvant Furmonertinib Plus Bevacizumab or Furmonertinib Monotherapy for Resectable and Potentially Resectable Stage III-IVA EGFR Mutation-Positive Lung Adenocarcinoma
Neoadjuvant Furmonertinib Plus Bevacizumab or Furmonertinib Monotherapy for Resectable and Potentially Resectable Stage III-IVA EGFR Mutation-Positive Lung Adenocarcinoma: A Randomized, Controlled, Open-label, Single-center Phase II Clinical Trial
Source: ClinicalTrials.gov · Last updated 17 Aug 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To explore the efficacy and safety of neoadjuvant furmonertinib combined with bevacizumab in the treatment of resectable and potentially resectable stage III-IVA EGFR mutation-positive lung adenocarcinoma.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 13 Aug 2022
- Start date
- 1 Feb 2022
- Primary completion date
- 1 Oct 2023
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Diseases
- Lung cancer
- NCT number
- NCT05503667
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 96
- From 1 Feb 2022 to the primary completion date, 1 Oct 2023
- 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
- The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure \[≥ Grade II specified by New York Heart Association (NYHA)\], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment;
- The patient had undergone other major systemic operations or suffered from severe trauma within 3 months before the trial;
Other illness
- The patient has undergone any systemic anti-cancer treatment for NSCLC, including cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.;
- The patient is a carrier of HIV;
- The patient is currently suffering from interstitial lung disease;
- The patient is allergic to furmonertinib or its any excipients;
- The patient is allergic to bevacizumab or its any excipients;
- There are any conditions under which the investigator considers the patient is not suitable to be enrolled.
Other
- The female patient is in pregnancy or lactation period;
Who the study is looking for
- Lung adenocarcinoma patient with EGFR sensitive mutation as confirmed by needle biopsy;
- At stage III-IVA (TNM Staging, Version 8) as identified by chest CT, PET-CT or/and EBUS;
- No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.);
- With the feasiblility or potential feasibility to receive radical surgery (radical lung lobectomy+systematic lymph node dissection);
- Good lung function that could tolerate surgical treatment;
- Aged \>= 18 years;
- At least one measurable tumor foci (the longest diameter measured by CT shall be \> 10 mm);
- Other major organs shall function well (liver, kidney, blood system, etc.):
- ECOG PS score shall be 0-1;
- The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial;
- The patient shall sign the Informed Consent Form.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.