AzTrials
AzTrials

Lung AdenocarcinomaPhase 2NCT07878871

Firmonertinib Plus Chemotherapy for Unresectable EGFR PACC-Mutant Stage III Lung Cancer: A Phase II Study

A Phase 2 study testing Firmonertinib and Platinum-based chemotherapy in people with Lung Adenocarcinoma and Stage III Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective, single-arm, multicenter Phase II clinical study. It aims to evaluate the efficacy and safety of Firmonertinib combined with chemotherapy in patients with unresectable Stage III lung adenocarcinoma harboring EGFR PACC mutations. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Firmonertinib and Platinum-based chemotherapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteChina
Study dates
Nov 2026to Dec 2031
Phase
Phase 2
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

  • Histologically confirmed locally advanced (Stage IIIA-IIIC according to the AJCC 9th edition) lung adenocarcinoma that is assessed by the investigator as unresectable or unsuitable for surgical resection.
  • Confirmed presence of EGFR PACC mutations by genetic testing at a tertiary Grade A hospital.
  • No prior local or systemic anti-tumor therapy for Stage III non-small cell lung cancer, including standard chemotherapy, biological therapy, targeted therapy, immunotherapy, or investigational therapy.
  • According to RECIST 1.1 criteria, at least one measurable lesion that has not been previously irradiated and has not undergone tissue biopsy during the screening period.
  • Fully understands the study and voluntarily signs the Informed Consent Form (ICF).
  • Age ≥ 18 years, both genders.
Show all 14Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, with no deterioration within 2 weeks prior to enrollment.
  • Life expectancy ≥ 12 weeks.
  • Adequate organ function:
  • Hematology: Absolute neutrophil count (ANC) ≥ 1500/µL; Platelet count ≥ 100×10^9/L; Hemoglobin ≥ 9.0 g/dL.
  • Renal: Serum creatinine ≤ 1.5 × ULN, or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula).
  • Hepatic: Total bilirubin ≤ 1.5 × ULN, or direct bilirubin within normal limits for subjects with total bilirubin > 1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN.
  • Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN. Exception: Subjects receiving anticoagulation therapy must have PT or APTT within the intended therapeutic range of the anticoagulant.
  • Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to the first dose. Women of childbearing potential and male subjects with partners of childbearing potential must agree to use highly effective contraception during the study and for 180 days after the last dose of study treatment.

Who cannot join

  • Subjects meeting any of the following exclusion criteria cannot be enrolled in this study:
  • Pathological type of squamous cell carcinoma or small cell lung cancer.
  • Known history of severe hypersensitivity reactions to the active or inactive excipients of Firmonertinib, or to drugs with a similar structure or class to Firmonertinib.
  • Prior systemic anti-tumor therapy for NSCLC, including investigational drug therapy.
  • History of (non-infectious) pneumonitis/interstitial lung disease requiring steroids, or current pneumonitis/interstitial lung disease requiring steroid therapy.
  • Known active autoimmune disease requiring systemic therapy.
Show all 13Show fewer
  • Any subject with known or suspected autoimmune disease or immunodeficiency, EXCEPT: Subjects with hypothyroidism who do not require hormone therapy or are receiving stable dose hormone replacement therapy; subjects with Type 1 diabetes mellitus whose blood glucose is stably controlled.
  • Uncontrolled active hepatitis B (defined as positive HBsAg at screening AND HBV-DNA level above the upper limit of normal of the testing laboratory at the study center. Exception: Subjects with HBV-DNA < 500 IU/mL within 28 days prior to enrollment, who have received at least 14 days of local standard antiviral therapy, and are willing to continue antiviral therapy during the study may be enrolled); Active hepatitis C (defined as positive hepatitis C virus surface antibody [HCsAb] at screening, with positive HCV-RNA).
  • Known human immunodeficiency virus (HIV) infection (known positive HIV antibody).
  • Known severe or uncontrolled underlying diseases, including but not limited to hemodynamically unstable cardiovascular events, symptomatic cerebrovascular events, or cirrhosis of Child-Pugh Grade A or higher within 6 months.
  • Any history or current evidence of diseases, treatments, or laboratory abnormalities that, in the investigator's judgment, may confound the trial results, interfere with the subject's participation in the full trial, or are not in the best interest of the subject.
  • Other malignancies other than non-small cell lung cancer within 5 years prior to the first dose. Malignancies with negligible risk of metastasis or death (e.g., expected disease-free survival > 5 years) and expected to achieve curative outcomes after treatment (e.g., adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, radically resected ductal carcinoma in situ) may be exempted.
  • Pregnancy or lactation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yongchang Zhang, MD, PhD contact

+86 0731-89762765

zhangyongchang@hnca.org.cn

Liang Zeng, MD, PhD contact

+86 073189762765

zengliang@hnca.org.cn

China1 site

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Yongchang Zhang, MD, PhD, +86 073189762765, zhangyongchang@hnca.org.cn

    Liang Zeng, MD, PhD, +86 073189762765, zengliang@hnca.org.cn

Other trials in China

About this study

Official title: Firmonertinib Combined With Chemotherapy for Unresectable EGFR PACC-Mutant Stage III Lung Adenocarcinoma: A Prospective, Single-Arm, Multicenter Phase II Clinical Study

This is a prospective, single-arm, multicenter Phase II clinical study. It aims to evaluate the efficacy and safety of Firmonertinib combined with chemotherapy in patients with unresectable Stage III lung adenocarcinoma harboring EGFR PACC mutations. Participants will receive Firmonertinib combined with standard chemotherapy. The primary objective is to assess the objective response rate (ORR). This study will provide important evidence for a potential new treatment option for this specific patient population.

Read the detailed description

Background: EGFR PACC mutations (P-loop and αC-helix compressing mutations) represent a distinct subtype of EGFR mutations with unique structural characteristics and potentially different responses to targeted therapies. There is an unmet clinical need for effective treatment regimens for patients with unresectable Stage III lung adenocarcinoma harboring these mutations. Firmonertinib is a highly selective third-generation EGFR-TKI with demonstrated efficacy. Combining targeted therapy with chemotherapy may provide synergistic anti-tumor effects.

Study Design: This is a prospective, single-arm, multicenter Phase II clinical study. Eligible patients will receive Firmonertinib in combination with chemotherapy.

Objectives: The primary objective of this study is to evaluate the objective response rate (ORR) of Firmonertinib combined with chemotherapy in this patient population. The secondary objectives include: To evaluate the 1-year and 3-year event-free survival (EFS) rates, surgical conversion rate, R0 resection rate, major pathological response (MPR), pathological complete response (pCR), event-free survival (EFS), and overall survival (OS).To assess the safety and tolerability of the combination regimen.

Significance: This study aims to provide robust clinical evidence for the efficacy and safety of Firmonertinib combined with chemotherapy, potentially establishing a new therapeutic option for patients with unresectable EGFR PACC-mutant Stage III lung adenocarcinoma.

Being tested
Firmonertinib, Platinum-based chemotherapy
Keywords
Firmonertinib, EGFR PACC mutation, Unresectable Stage III, Lung Adenocarcinoma
Medical subject headings
Adenocarcinoma of Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FirmonertinibDrug

    Firmonertinib mesylate tablets, 160 mg, oral administration, once daily. Administered during induction and consolidation phases.

  • Platinum-based chemotherapyDrug

    Pemetrexed (500 mg/m²) combined with Carboplatin or Cisplatin. Administered during the 3-4 cycles of induction therapy

Study groups in NCT07878871
Study groupRoleWhat they receive
Firmonertinib Combined with ChemotherapyExperimentalParticipants will receive induction therapy consisting of Firmonertinib (160 mg orally once daily, continuously) combined with platinum-based chemotherapy (Pemetrexed 500 mg/m² plus Carboplatin or Cisplatin) for 3-4 cycles. Following induction, an MDT assessment will determine subsequent treatment (surgery, radiotherapy, or other therapies). Patients confirmed for adjuvant/consolidation will receive Firmonertinib (160 mg orally once daily) for up to 3 years.
Receives: Drug: Firmonertinib; Drug: Platinum-based chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Proportion of participants achieving complete response (CR) or partial response (PR) as assessed by investigators according to RECIST v1.1 criteria

    Measured: From baseline to the end of study treatment (up to approximately 36 months)

Secondary outcomes (7)

  1. 1-year and 3-year Event-Free Survival (EFS) Rate

    Proportion of participants who are event-free at 1 year and 3 years from enrollment. Events are defined as disease progression, relapse, or death from any cause

    Measured: At 1 year and 3 years post-enrollment

  2. Surgical Conversion Rate

    Proportion of participants with unresectable disease at baseline who achieve resectability and undergo surgery after induction therapy

    Measured: After 3-4 cycles of induction therapy (up to approximately 6 months)

  3. R0 Resection Rate

    Proportion of participants who undergo surgical resection with microscopically negative margins (R0 resection)

    Measured: At the time of surgery (up to approximately 6 months)

  4. Major Pathological Response (MPR) and Pathological Complete Response (pCR) Rate

    Proportion of participants achieving MPR (≤10% viable tumor cells) or pCR (no viable tumor cells) in resected specimens

    Measured: At the time of surgery (up to approximately 6 months)

  5. Event-Free Survival (EFS)

    Time from enrollment to the first occurrence of disease progression, relapse, or death from any cause

    Measured: From enrollment to the end of study (up to approximately 36 months)

  6. Overall Survival (OS)

    Time from enrollment to death from any cause

    Measured: From enrollment to the end of study (up to approximately 36 months)

  7. Safety and Tolerability

    Incidence, severity, and relatedness of adverse events (AEs) and serious adverse events (SAEs) according to NCI-CTCAE v5.0

    Measured: From first dose to 30 days after the last dose of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionDec 2031 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a prospective, single-arm, multicenter Phase II clinical study. All enrolled participants will receive Firmonertinib combined with standard chemotherapy. There is no randomization or control group in this study.
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07878871
Sponsor's protocol ID
IIT331
Status last verified
Oct 2026
First submitted
10 Oct 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because the informed consent forms signed by the participants do not permit the public sharing of individual data. Additionally, local ethical and regulatory requirements regarding patient privacy protection restrict the sharing of individual data outside the study team

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Firmonertinib and Platinum-based chemotherapy in people with Lung Adenocarcinoma and Stage III Lung Cancer, run by Hunan Province Tumor Hospital at 1 site 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 14 inclusion and 13 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: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Yongchang Zhang, MD, PhD (+86 0731-89762765, zhangyongchang@hnca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: From baseline to the end of study treatment (up to approximately 36 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07878871.

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 16 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in