NSCLCPhase 2NCT07181499

Sequential Chemotherapy With Befotertinib in Non-Small Cell Lung Cancer (NSCLC) Patients With Resistance to Third-Generation EGFR-TKI

A Phase 2 study testing Befotertinib and Pemetrexed + Carboplatin in people with NSCLC and Adjuvant Drug Therapy, run by Betta Pharmaceuticals Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: NSCLC, Adjuvant Drug Therapy, EGFR
What is being tested?: Befotertinib and Pemetrexed + Carboplatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 2 sitesChina
Study dates: Sep 2025to Dec 2028
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

Age ≥18 years;
Histologically or cytologically confirmed advanced or metastatic non-squamous NSCLC; and prior resistance to third-generation EGFR TKIs, with EGFR-sensitive mutations confirmed via tissue or blood samples (defined as: 19 Del or 21 L858R);
Exclusion of small cell lung cancer (SCLC) or squamous cell carcinoma (SqCC) transformation, and known NSCLC with clear targetable mutations for targeted therapy, such as HER2, MET amplification (GCN ≥ 5), KRAS G12C mutation, BRAF V600E mutation, RET fusion mutation, ALK fusion mutation, NTRK fusion mutation, etc.;
ECOG performance status (PS) score of 0-2;
Life expectancy of at least 12 weeks;
Ability to swallow oral medications;

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Adequate organ system function, defined as follows and determined based on investigator judgment:
Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
Platelets ≥ 100 x 10⁹/L;
Hemoglobin ≥ 9 g/dL (≥ 90 g/L). Note: Blood transfusions are permitted to achieve the required hemoglobin level;
Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);
If no liver metastases: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; if liver metastases present: ≤ 5 × ULN;
Creatinine ≤1.5 × ULN. If ≥1.5 × ULN, patients remain eligible if the Cockcroft-Gault-calculated creatinine clearance ≥50 mL/min (0.83 mL/s);
Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to study drug initiation and agree to use a medically approved highly effective contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 3 months after the last study drug administration; Male subjects with female partners of childbearing potential must be surgically sterilized or agree to use an effective method of contraception during the study period and for 3 months after the last study dose.
Voluntarily agree and be capable of adhering to the trial and follow-up procedures.
Be able to understand the nature of the trial and complete the written informed consent form.

Who cannot join

Rare EGFR mutations;
Prior treatment with pemetrexed and platinum-based chemotherapy regimens;
Advanced and/or symptomatic brain metastases (measurable or non-measurable) and/or leptomeningeal metastases;
Active hepatitis B (serum HBV DNA ≥10⁴ copies/mL [i.e., 20,000 IU/mL]), hepatitis C virus antibody positive, HIV antibody positive, or treponema pallidum antibody positive;
Women of childbearing potential with a positive serum pregnancy test within 7 days prior to treatment initiation, pregnant or lactating women, or male and female subjects not using effective contraception or planning pregnancy during treatment and for 3 months post-treatment;
Patients who used or require concomitant use of the following drugs within 14 days prior to the first dose or during treatment: drugs associated with QTc prolongation and/or risk of torsades de pointes ventricular tachycardia; strong CYP3A inhibitors or inducers;

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Patients who underwent major surgery or immunotherapy within 4 weeks prior to the first dose; patients who received radiotherapy within 2 weeks prior to the first dose.
Imaging (CT or MRI) demonstrating tumor invasion of major vessels, or a high likelihood of tumor invasion into critical vessels causing fatal hemorrhage during the study period;
History of interstitial lung disease, drug-induced interstitial disease, or any clinically evident active interstitial lung disease; presence of idiopathic pulmonary fibrosis identified on baseline CT scan;
Other severe acute or chronic medical conditions, including uncontrolled diabetes, medical or psychiatric disorders, or laboratory abnormalities, that in the investigator's judgment may increase study-related risks or interfere with interpretation of study results;
Other conditions deemed by the investigator to be unsuitable for participation in this trial.

Trial locations and contacts

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

Shaodong Hong contact

15920527656

hongshd@sysucc.org.cn

China2 sites, 2 recruiting

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Shao dong Hong, 15920527656, hongshd@sysucc.org.cn
Recruiting
The Cancer Center of The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong
Xiaofeng Pei, +86 139 2338 1037, peixf3@mail.sysu.edu.cn
Recruiting

Other trials in China

About this study

Official title: A Study Evaluating the Efficacy and Safety of Pemetrexed Combined With Platinum-Based Chemotherapy Followed by Befotertinib in Patients With Non-Small Cell Lung Cancer After Third-Generation EGFR TKI Resistance

Non-small cell lung cancer (NSCLC) accounts for over 85% of lung cancers. Approximately 30-40% of East Asian adenocarcinoma patients harbor EGFR mutations. Third-generation EGFR-TKIs achieve a median PFS of about 20 months as first-line therapy, but resistance eventually develops. Studies like MARIPOSA-2 confirm that amivantamab combined with chemotherapy ± lazertinib or immunotherapy regimens (ivucitinib/sintilimab + bevacizumab + chemotherapy) can extend median PFS post-resistance from approximately 4 months to 6-8 months. As a third-generation TKI, befitinib has demonstrated PFS of 16-22 months in both first-line and post-T790M mutation settings. This study aims to further evaluate the feasibility and safety of "pemetrexed + carboplatin followed by befotertinib" for patients resistant to third-generation TKIs.

Conditions: NSCLC, Adjuvant Drug Therapy, EGFR
Being tested: Befotertinib, Pemetrexed + Carboplatin

What participants receive

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

BefotertinibDrug
Befotertinib was administered orally at a starting dose of 75 mg per day for 21 days, which could be increased to 100 mg per day if grade 2 or higher thrombocytopenia or headache did not occur within 21 days, or maintained at the original dose (75 mg per day) if grade 2 or higher thrombocytopenia or headache occurred within 21 days.
Pemetrexed + CarboplatinDrug
pemetrexed (500 mg/m²) and carboplatin (AUC 5), administered every 3 weeks, for a total of 2~4 cycles.

Study groups in NCT07181499
Study group	Role	What they receive
Group 1	Experimental	pemetrexed (500 mg/m2) and carboplatin (AUC 5), administered every 3 weeks. After 2 to 4 cycles, received Befotertinib (75-100 mg) Receives: Drug: Befotertinib; Drug: Pemetrexed + Carboplatin

What is being measured

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

progression free survival
It refers to the time from the start of treatment until the tumor progresses or until death occurs for any reason (whichever occurs first).
Measured: From enrollment to the end of treatment at 12 months

Secondary outcomes (4)

objective remission rate
Objective Response Rate was defined as the percentage of participants whose tumor lesions disappear completely or diameters reduced by at least 30% as assessed by RECIST1.1.
Measured: From enrollment to the end of treatment at 12 month
Disease control rate
Disease Control Rate was defined as the total percentage of participants except for those with tumor lesions diameters increased by at least 20% as assessed by RECIST1.1.
Measured: From enrollment to the end of treatment at 12 months
overall survival
Overall survival was defined as the time from participants' treatment to their death due to any cause.
Measured: From enrollment to the end of treatment at 36 months
adverse event
The number of participants with treatment-related adverse events as assessed by CTCAE v4.0 would be recorded and calculated after them participating into the study and taking the experimental drug.
Measured: From enrollment to the end of treatment at 12 months

Timeline

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

Sep 2025Dec 2028

First posted18 Sep 2025
Study startSep 2025 (estimated)
Primary completionNov 2028 (estimated)
Study completionDec 2028 (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 Betta Pharmaceuticals Co., Ltd.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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 28 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07181499
Sponsor's protocol ID: BD-BF-IV028
Status last verified: Sep 2025
First submitted: 10 Sep 2025
Last updated: 30 Sep 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study Evaluating the Efficacy and Safety of Pemetrexed Combined With Platinum-Based Chemotherapy Followed by Befotertinib in Patients With Non-Small Cell Lung Cancer After Third-Generation EGFR TKI Resistance
ClinicalTrials.gov ID: NCT07181499
Acronym / sponsor ID: BD-BF-IV028
Conditions: NSCLC, Adjuvant Drug Therapy, EGFR
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 28 participants (estimated)
Lead sponsor: Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: Sep 2025 (estimated)
Primary completion: Nov 2028 (estimated)
Study completion: Dec 2028 (estimated)
First posted: 18 Sep 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Group 1	Experimental	Drug: Befotertinib, Drug: Pemetrexed + Carboplatinpemetrexed (500 mg/m2) and carboplatin (AUC 5), administered every 3 weeks. After 2 to 4 cycles, received Befotertinib (75-100 mg)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Age ≥18 years;
Histologically or cytologically confirmed advanced or metastatic non-squamous NSCLC; and prior resistance to third-generation EGFR TKIs, with EGFR-sensitive mutations confirmed via tissue or blood samples (defined as: 19 Del or 21 L858R);
Exclusion of small cell lung cancer (SCLC) or squamous cell carcinoma (SqCC) transformation, and known NSCLC with clear targetable mutations for targeted therapy, such as HER2, MET amplification (GCN ≥ 5), KRAS G12C mutation, BRAF V600E mutation, RET fusion mutation, ALK fusion mutation, NTRK fusion mutation, etc.;
ECOG performance status (PS) score of 0-2;
Life expectancy of at least 12 weeks;

Key exclusion criteria (11 listed)

Rare EGFR mutations;
Prior treatment with pemetrexed and platinum-based chemotherapy regimens;
Advanced and/or symptomatic brain metastases (measurable or non-measurable) and/or leptomeningeal metastases;
Active hepatitis B (serum HBV DNA ≥10⁴ copies/mL [i.e., 20,000 IU/mL]), hepatitis C virus antibody positive, HIV antibody positive, or treponema pallidum antibody positive;
Women of childbearing potential with a positive serum pregnancy test within 7 days prior to treatment initiation, pregnant or lactating women, or male and female subjects not using effective contraception or planning pregnancy during treatment and for 3 months post-treatment;

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
BefotertinibBefotertinib was administered orally at a starting dose of 75 mg per day for 21 days, which could be increased to 100 mg per day if grade 2 or higher thrombocytopenia or headache did not occur within 21 days, or maintained at the original dose (75 mg per day) if grade 2 or higher thrombocytopenia or headache occurred within 21 days.	Drug	Group 1
Pemetrexed + Carboplatinpemetrexed (500 mg/m²) and carboplatin (AUC 5), administered every 3 weeks, for a total of 2~4 cycles.	Drug	Group 1

Primary outcome

progression free survival
Time frame: From enrollment to the end of treatment at 12 months
It refers to the time from the start of treatment until the tumor progresses or until death occurs for any reason (whichever occurs first).

4 secondary outcomes

objective remission rate
Time frame: From enrollment to the end of treatment at 12 month
Disease control rate
Time frame: From enrollment to the end of treatment at 12 months
overall survival
Time frame: From enrollment to the end of treatment at 36 months
adverse event
Time frame: From enrollment to the end of treatment at 12 months

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 30 Sep 2025.

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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.

Shaodong Hong contact

15920527656

hongshd@sysucc.org.cn

XiaoFeng Pei study director

The Fifth Affliated Hospital, Sun Yat-sen University

YingNi Lian principal investigator

First People's Hospital of Zhaoqing

DongYing Liu principal investigator

Jiangmen Central Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Befotertinib and Pemetrexed + Carboplatin in people with NSCLC and Adjuvant Drug Therapy, run by Betta Pharmaceuticals Co., Ltd. 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 16 inclusion and 11 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 30 Sep 2025. 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. 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 Shaodong Hong (15920527656, hongshd@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival (time frame: From enrollment to the end of treatment at 12 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 NCT07181499.

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 30 Sep 2025.