Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05430802

Neoadjuvant Furmonertinib and Cisplatin/Pemetrexed as in EGFR Mutated Stage IIA-IIIB Resectable NSCLC (FORESEE)

In this single-arm, phase II clinical trial, patients with resectable, EGFR-mutated, stage II-IIIB NSCLC received neoadjuvant therapy with furmonertinib (oral, 80 mg once daily, stopped 1 week preoperatively) in combination with platinum-based doublet chemotherapy every 3 weeks for a total of 3 cycles. Surgery was performed 4-6 weeks after chemotherapy. The primary endpoint was objective response rate (ORR). Secondary endpoints included the pathological complete response (pCR) rate, major pathological response (MPR) rate, TNM downstaging rate, R0 resection rate, EFS, overall survival (OS), drug safety and surgical complications.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • With written informed consent before any study procedure
  • Histology or cytology diagnose of non-small cell lung cancer within 60 days
  • Stage IIA-IIIB (T3N2M0 only), with resectable lesion(s) by radiology
  • EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
  • Without prior anti-tumor treatment
  • With at least one measurable lesions
  • ECOG performance status 0-1
  • Using adequate and effective contraception, women should refrain from breastfeeding and have a negative pregnancy test prior to the first administration of the study drug if within during child-bearing age

Exclusion criteria

  • EGFR Exon 20 insertions positive
  • Mixed with small cell cancer, or other mixed types of lung cancer
  • Any prior anti-tumor treatment
  • Major surgery within 4 weeks before enrollment
  • Women with pregnancy or breastfeeding
  • Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days before enrollment; use of traditional Chinese medicine with anti-tumor effect within 21 days before enrollment
  • With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
  • With severe or uncontrolled systemic disease such as uncontrolled hypertention, diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction within 1 year, active hemorrhage, active HBV/HCV/HIV or other infections requiring infusion treatment
  • Severe gastrointestinal diseases which may affect the intake and absorption of study drug
  • Prolongation of ECG QTc or with relative risk factors
  • History of interstitial lung disease or with relative risk factors
  • Inadequate organ function of hematology, liver and kidney
  • Allergic to study drugs or any component
  • Poor adherence or other situation judged by investigator
  • Patients who had participated other clinical studies of tumors

Treatment and study plan

Furmonertinib+cisplating/pemetrexed

Drug

Furmonertinib 80mg/d for 9 weeks and cisplating75mg/m2 d1 iv + pemetrexed 500mg/m2 d1 iv in 21-day cycles for 3 cycles

Primary outcomes

  1. Objective response rate

    Time frame: 7 days before surgery

    the proportion of patients achieving complete response (CR) or partial response (PR) as assessed by investigators according to RECIST version 1.1

Secondary outcomes

  1. Major pathological response rate

    Time frame: 7 days after surgery

    MPR was defined as the presence of ≤10% residual viable tumor cells in the primary tumor and all lymph nodes from surgical specimens following R0 resection, and the MPR rate was subsequently calculated as the proportion of patients who achieved MPR

  2. Pathological complete response rate

    Time frame: 7 days after surgery

    pCR was defined as the absence of viable tumor cells in the primary tumor and all sampled regional lymph nodes from surgical specimens following R0 resection, and the pCR rate was calculated as the proportion of patients achieving this response

  3. R0 resection rate

    Time frame: 7 days after surgery

    the proportion of patients achieving R0 resection among all patients undergoing tumor resection surgery

  4. the TNM downstaging rate

    Time frame: 7 days before surgery

    defined as the proportion of patients whose post-neoadjuvant therapy TNM stage (prior to surgery) was lower than their baseline TNM stage

  5. Event-free survival

    Time frame: 2 years

    defined as the time from the date of informed consent to loss of surgical eligibility due to disease progression, postoperative recurrence, or death from any cause

  6. Overall survival

    Time frame: Approximately 5 years following the first dose of study drugs

    The time from enrolment to death of any reason

  7. drug safety and surgical complications

    Time frame: Adverse events (AEs) will be followed up for 30 days, serious adverse events (SAEs) will be followed up until resolution (assessed up to 60 days), and surgical complications will be followed up for 90 days.

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 and Number of participants with surgical complications as assessed by Clavien-Dindo

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Lei, MD

CONTACT

[email protected]

15094079004

Sponsors and collaborators

Lead sponsor

Tang-Du Hospital

Other

Registry information

Official study title

Furmonertinib Combined With Cisplatin/Pemetrexed as Neoadjuvant Therapy in EGFR Mutated Stage IIA-IIIB Resectable Non-small Cell Lung Cancer (FORESEE): a Prospective, Open-label, Single-arm, Phase 2 Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 24, 2022
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.