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| Name | Class |
|---|---|
| ArriVent BioPharma, Inc. | INDUSTRY |
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This is a Phase 3, global, double-blind, randomized, controlled multicenter clinical study to assess the efficacy and safety of adjuvant treatment with firmonertinib versus placebo in participants with Stage IB-IIIB NSCLC with uncommon EGFR mutations (exon 20 insertions, PACC and classical-like mutations) after complete surgical resection with or without adjuvant chemotherapy.
About 338 eligible participants will be enrolled and randomized in a 1:1 ratio to receive either firmonertinib 240 mg QD or placebo QD in 21-day treatment cycles. Before randomization, the participant must have undergone complete surgical resection (R0 resection), must have sufficiently recovered from surgery, and must have completed adjuvant chemotherapy (if applicable). The participants will receive firmonertinib or placebo as adjuvant treatment until unacceptable toxicity, withdrawal of informed consent, disease recurrence, initiation of new antitumor treatment, completion of treatment, or other end of treatment reason is met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Firmonertinib | Experimental | Firmonertinib: 240 mg, QD, orally |
|
| Placebo | Placebo Comparator | Placebo: 240 mg, QD, orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Firmonertinib | Drug | Firmonertinib: 240 mg, QD, orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival (DFS) | DFS as assessed by the investigator in Stage II- IIIB. DFS defined as the time from the date of randomization to the first observation of disease recurrence (by pathological diagnosis or imaging) or death caused by any reason, whichever occurs first. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival (DFS) | DFS as assessed by the blinded independent central review (BICR) in Stage II-IIIB | Up to 3 years |
| Disease free survival (DFS) | DFS as assessed by the investigator in Stage IB-IIIB; DFS as assessed by the BICR in Stage IB-IIIB |
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Inclusion Criteria:
Exclusion Criteria:
A participant would be excluded from the study if he/she meets any of the following:
NSCLC with EGFR Exon 19 deletion or L858R or C797S mutation.
Incomplete resection (R1/R2) or segmentectomy or wedge resection only.
Prior treatment with any of the following:
Concurrent malignant tumors other than the primary tumor; participants with cancers that can be treated locally and cured may be eligible.
Previous ILD (including drug-induced ILD) or active ILD/active radiation pneumonitis.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zhang, Master | Contact | 020-87342288 | Zhangli6@mall.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, Master | Sun Yat-sen University | Principal Investigator |
| Fan Yang, Doctor | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| Placebo |
| Drug |
Placebo: 240 mg, QD, orally |
|
| Up to 3 years |
| Disease free survival rates | 2-, 3-, and 5-year DFS rates as assessed by the investigator and BICR in Stage II-IIIB and in Stage IB-IIIB | Up to 5 years |
| Overall survival (OS) | OS defined as the time from the date of randomization to the date of death due to any cause, in Stage II-IIIB and in Stage IB-IIIB | Up to 5 years |
| Overall survival rates | 2-, 3-, and 5-year OS rates in Stage II-IIIB and in Stage IB-IIIB | Up to 5 years |
| Adverse event (AE) | Incidence and severity of AEs, with severity as determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) | Up to 5 years |
| Sun Yat-sen University Cancer Center | Recruiting | Guangdong | Guangzhou | 510060 | China |
|