Not Yet RecruitingPhase 1/2

A Study to Evaluate ANS014004 in Combination With EGFR-TKI in Non-Small Cell Lung Cancer

United States253 participantsStarted 2026-06

Plain-language summary

Protocol Title A Study to Evaluate ANS014004 in Combination with EGFR-TKI in Patients with EGFR Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer The main purpose of this research study is to Find a safe and tolerable dose of two investigational drugs, ANS014004 and PLB1004, when used together. Learn how effective this drug combination is at treating a type of lung cancer called "EGFR mutation-positive non-small cell lung cancer (NSCLC)" that has spread to other parts of the body (locally advanced or metastatic). This study is trying to answer the following questions: Safety \& Dosing: What are the side effects of combining ANS014004 and PLB1004? What is the best dose to use that patients can tolerate well? Effectiveness: Can this combination of drugs help shrink patients' tumors or stop them from growing? Background Information For patients with advanced lung cancer that has a specific gene change called an "EGFR mutation," targeted therapies known as EGFR-TKIs are a standard treatment. While these treatments often work well at first, most tumors eventually stop responding to the drug (this is called "acquired resistance"). The investigational drug ANS014004 is designed to block a protein called MET, which is one of the ways that tumors become resistant to EGFR-TKIs. The researchers believe that by combining ANS014004 with the EGFR-TKI PLB1004, they may be able to prevent or delay resistance, offering patients a more effective and longer-lasting treatment option. How will the study be conducted? This study is divided into two parts: Part 1 (Dose Escalation and Optimization): A small number of participants will receive different dose levels of ANS014004 combined with a fixed dose of PLB1004. The goal is to find the safest and most tolerable dose combination. Part 2 (Phase II Study): Once a recommended dose is identified, more participants will be enrolled to further evaluate how well the drug combination works against the cancer. Throughout the study, participants' health will be closely monitored, and their tumors will be measured regularly using imaging scans (like CT scans) to see how they respond to the treatment.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female participants ≥18years of age at the time of signing the informed consent form.
. Patients with histologically or cytologically confirmed diagnosis of unresectable locally advanced (Stage IIIB and IIIC) or metastatic (Stage IV) NSCLC (according to the lung cancer staging criteria, refer to the eighth edition of the American Joint Committee on Cancer \[AJCC\] Lung Cancer Staging).
. Have a documented EGFR positive mutation (EGFR classic mutations including ex19del and ex21 L858R, uncommon mutations and ex20 insertion mutations) in tumor tissue samples or pleural fluid or blood samples.
. For Phase Ib dose escalation: have disease progression after the existing standard of care or intolerance to the existing standard of care or inappropriate or no effective standard of care is available (standard of care is defined as treatment recommended by the National Comprehensive Cancer Network \[NCCN\] guidelines \[including but not limited to chemotherapy, radiotherapy, targeted therapy based on mutation status, immunotherapy, and surgery\]). For participants who are considered intolerant to or ineligible for available standard therapy, or for whom effective standard therapy does not exist, the documentation of these reasons is required.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with dose-limiting toxicity (DLT) during the DLT observation period (Phase Ib Dose Escalation)

Timeframe: 2 years.

Maximum tolerated dose (MTD) of ANS014004 in combination with PLB1004 (Phase Ib Dose Escalation)

Timeframe: 2 years

Objective Response Rate (ORR) assessed by investigator per RECIST v1.1 (Phase Ib Dose Optimization, Phase II)

Timeframe: 2 years

Recommended Phase 2 Dose (RP2D) of ANS014004 in combination with PLB1004 (Phase Ib Dose Optimization)

Timeframe: 2 years.

Trial details

NCT IDNCT07285148

SponsorBeijing Pearl Biotechnology Limited Liability Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-12

View on ClinicalTrials.gov More Non-Small Cell Lung Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female participants ≥18years of age at the time of signing the informed consent form.
. Patients with histologically or cytologically confirmed diagnosis of unresectable locally advanced (Stage IIIB and IIIC) or metastatic (Stage IV) NSCLC (according to the lung cancer staging criteria, refer to the eighth edition of the American Joint Committee on Cancer \[AJCC\] Lung Cancer Staging).
. Have a documented EGFR positive mutation (EGFR classic mutations including ex19del and ex21 L858R, uncommon mutations and ex20 insertion mutations) in tumor tissue samples or pleural fluid or blood samples.
. For Phase Ib dose escalation: have disease progression after the existing standard of care or intolerance to the existing standard of care or inappropriate or no effective standard of care is available (standard of care is defined as treatment recommended by the National Comprehensive Cancer Network \[NCCN\] guidelines \[including but not limited to chemotherapy, radiotherapy, targeted therapy based on mutation status, immunotherapy, and surgery\]). For participants who are considered intolerant to or ineligible for available standard therapy, or for whom effective standard therapy does not exist, the documentation of these reasons is required.

What they're measuring

Number of participants with dose-limiting toxicity (DLT) during the DLT observation period (Phase Ib Dose Escalation)

Timeframe: 2 years.

Maximum tolerated dose (MTD) of ANS014004 in combination with PLB1004 (Phase Ib Dose Escalation)

Timeframe: 2 years

Objective Response Rate (ORR) assessed by investigator per RECIST v1.1 (Phase Ib Dose Optimization, Phase II)

Timeframe: 2 years

Recommended Phase 2 Dose (RP2D) of ANS014004 in combination with PLB1004 (Phase Ib Dose Optimization)

Timeframe: 2 years.

A Study to Evaluate ANS014004 in Combination With EGFR-TKI in Non-Small Cell Lung Cancer

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

A Study to Evaluate ANS014004 in Combination With EGFR-TKI in Non-Small Cell Lung Cancer

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria