NSCLCPhase 3FIRMOSTNCT07010419
A Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB - IIIB NSCLC With Uncommon Epidermal Growth Factor Receptor (EGFR) Mutations, Following Complete Surgical Resection With or Without Adjuvant Chemotherapy（FIRMOST）
A Phase 3 study testing Firmonertinib in people with NSCLC and Adjuvant Treatment, run by Allist Pharmaceuticals, Inc. at 2 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Adjuvant Treatment
- What is being tested?
- Firmonertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 338 participants
- Where
- 2 sitesChina
- Study dates
- 28 May 2025to 30 Apr 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the Informed Consent Form (ICF).
- Aged ≥ 18 years old. Participants from Japan/Taiwan aged ≥ 20 years old.
- Histologically confirmed diagnosis of primary non-small cell lung cancer (NSCLC) of predominantly non-squamous histology.
- Underwent complete surgical resection of primary lung cancer and systematic lymph node dissection (R0 resection).
- Classified post-operatively as Stage IB, II, IIIA, or IIIB (T3N2M0 only) on the basis of pathologic criteria, with the disease staging following the 9th Edition TNM Staging Classification: Lung Cancer issued by Union for International Cancer Control (UICC) and American Joint Committee on Cancer (AJCC).
- Documented results of the presence of uncommon EGFR mutations (exon 20 insertion mutations, PACC mutations, and/or classical-like mutations, either as single mutations or as co-mutations), in tumor tissue or blood via a validated NGS or validated PCR assay.
Who cannot join
- 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:
- Prior treatment with any antineoplastic therapy other than standard platinum-based doublet adjuvant chemotherapy.
- prior treatment with neoadjuvant therapy.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
CuiCui Cong, 010-88324516, rmyyllwyh@163.com
- Recruiting
Sun Yat-sen University Cancer Center
Guangdong, Guangzhou, 510060
Sun Yat-sen University Cancer Center Sun Yat-sen University Cancer Center, 020-87343009, llwyh@sysucc.org.cn
About this study
Official title: A Global Phase 3, Double-Blind, Randomized, Controlled Multicenter Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB - IIIB NSCLC With Uncommon Epidermal Growth Factor Receptor (EGFR) Mutations, Following Complete Surgical Resection With or Without Adjuvant Chemotherapy (FIRMOST)
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.
- Conditions
- NSCLC, Adjuvant Treatment
- Being tested
- Firmonertinib, Placebo
- Keywords
- EGFR, NSCLC, Firmonertinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FirmonertinibDrug
Firmonertinib: 240 mg, QD, orally
PlaceboDrug
Placebo: 240 mg, QD, orally
| Study group | Role | What they receive |
|---|---|---|
| Firmonertinib | Experimental | Firmonertinib: 240 mg, QD, orally Receives: Drug: Firmonertinib |
| Placebo | Placebo comparator | Placebo: 240 mg, QD, orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 years
Secondary outcomes (6)
Disease free survival (DFS)
DFS as assessed by the blinded independent central review (BICR) in Stage II-IIIB
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 5 years
Overall survival rates
2-, 3-, and 5-year OS rates in Stage II-IIIB and in Stage IB-IIIB
Measured: 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)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start28 May 2025
- Primary completion31 Oct 2028 (estimated)
- Study completion30 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Allist Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allist Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ArriVent BioPharma, Inc.
- Responsible party
- Sponsor
- Investigators
- Li Zhang, Master, Principal investigator, Sun Yat-Sen University Cancer CenterFan Yang, Doctor, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010419
- Sponsor's protocol ID
- FURMO-005
- Acronym
- FIRMOST
- Status last verified
- Aug 2026
- First submitted
- 20 May 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Phase 3, Double-Blind, Randomized, Controlled Multicenter Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB - IIIB NSCLC With Uncommon Epidermal Growth Factor Receptor (EGFR) Mutations, Following Complete Surgical Resection With or Without Adjuvant Chemotherapy (FIRMOST)
- ClinicalTrials.gov ID
- NCT07010419
- Acronym / sponsor ID
- FIRMOST / FURMO-005
- Conditions
- NSCLC, Adjuvant Treatment
- Keywords
- EGFR, NSCLC, Firmonertinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Allist Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ArriVent BioPharma, Inc.
- Study start
- 28 May 2025 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 30 Apr 2032 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Firmonertinib | Experimental | Drug: FirmonertinibFirmonertinib: 240 mg, QD, orally |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: 240 mg, QD, orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sign the Informed Consent Form (ICF).
- Aged ≥ 18 years old. Participants from Japan/Taiwan aged ≥ 20 years old.
- Histologically confirmed diagnosis of primary non-small cell lung cancer (NSCLC) of predominantly non-squamous histology.
- Underwent complete surgical resection of primary lung cancer and systematic lymph node dissection (R0 resection).
- Classified post-operatively as Stage IB, II, IIIA, or IIIB (T3N2M0 only) on the basis of pathologic criteria, with the disease staging following the 9th Edition TNM Staging Classification: Lung Cancer issued by Union for International Cancer Control (UICC) and American Joint Committee on Cancer (AJCC).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FirmonertinibFirmonertinib: 240 mg, QD, orally | Drug | Firmonertinib |
| PlaceboPlacebo: 240 mg, QD, orally | Drug | Placebo |
Primary outcome
Disease free survival (DFS)
Time frame: Up to 3 years
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.
6 secondary outcomes
Disease free survival (DFS)
Time frame: Up to 3 years
Disease free survival (DFS)
Time frame: Up to 3 years
Disease free survival rates
Time frame: Up to 5 years
Overall survival (OS)
Time frame: Up to 5 years
Overall survival rates
Time frame: Up to 5 years
Adverse event (AE)
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Zhang, Master principal investigator
Sun Yat-Sen University Cancer Center
Fan Yang, Doctor principal investigator
Peking University People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Firmonertinib in people with NSCLC and Adjuvant Treatment, run by Allist Pharmaceuticals, Inc. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Zhang, Master (020-87342288, Zhangli6@mall.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (DFS) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.