Active — Not RecruitingPhase 2

Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Non-small Cell Lung Cancer

China56 participantsStarted 2021-12-14

Plain-language summary

This is a phase II, single-arm, open-label study to evaluate the efficacy and safety of the third generation tyrosine kinase inhibitors (TKIs) Almonertinib (HS-10296) as neoadjuvant and adjuvant therapy for potential resectable stage III EGFR mutation-positive Non-small Cell Lung Cancer.

Who can participate

Age range

18 Years – 75 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: * NSCLC patient with EGFR sensitive mutation as confirmed by needle biopsy; * At stage III (TNM Staging, Version 8) as identified by chest CT, PET-CT or/and EBUS; * No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.); * With the feasibility to receive radical surgery ; * Good lung function that could tolerate surgical treatment; * Aged 18-75 years; * At least one measurable tumor foci (the longest diameter measured by CT shall be \> 10 mm); * Other major organs shall function well (liver, kidney, blood system, etc.): * ECOG PS score shall be 0-1; * The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial; * The patient shall sign the Informed Consent Form. Exclusion Criteria: * The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.; * The patient suffered from other cancers besides NSCLC (except cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor \[includ…

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

Objective response rate (ORR)

Timeframe: up to 4 months

Trial details

NCT IDNCT04685070

SponsorShanghai Pulmonary Hospital, Shanghai, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Non-small Cell Lung Cancer Stage III trials

Who can participate

Age range

18 Years – 75 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.