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New pill shows promise against lung cancer brain metastases

NCT ID NCT03653546

Disease control Sponsor: Alpha Biopharma (Jiangsu) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a new drug called AZD3759 against standard targeted therapies (erlotinib or gefitinib) in 492 people with advanced EGFR-mutant lung cancer that had spread to the brain. The goal was to see if AZD3759, which is designed to better reach the brain, could keep the cancer from growing longer. Results showed that AZD3759 improved progression-free survival compared to standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD3759 (a targeted therapy pill that crosses into the brain)
What this could lead to
If it works, this could offer a more effective first-line treatment for people with EGFR-mutant lung cancer that has spread to the brain, potentially delaying disease progression.
What could go wrong
This is a completed Phase II/III trial, but results may not apply to all patients. Side effects and long-term benefits are still being evaluated, and the drug is not yet widely approved.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

492 people

The number who actually took part.

Started

Oct 2018

Finished

Jul 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Properly completed patient informed consent 2. Male or female aged at least 18 years 3. Histologically or cytologically confirmed diagnosis of NSCLC with activating EGFR mutations including L858R and/or Exon19Del. EGFR mutation status will be determined by local or central laboratory testing on tumour tissue or plasma utilizing a validated methodology which has been approved by the regulatory authority. 4. No prior treatment with chemotherapy, EGFR-TKIs, or biological therapies that are considered first line treatment for advanced NSCLC. 5. All patients must have a documented diagnosis of advanced (Stage IV) NSCLC with Magnetic Resonance Imaging (MRI) documented CNS metastases that include brain metastases (BM). BM + patients with co- existent leptomeningeal involvement are eligible for the study. 6. Eligible patients are not candidates for definitive surgical resection or radiation of all lesions in the opinion of the treating physician. 7. All patients must be stable without any systemic (oral or parenteral) corticosteroid or anticonvulsant therapy for at least 2 weeks prior to study treatment. Inhaled non-absorbable and topical corticosteroid use are permitted as indicated. 8. Patients may have prior placement of a properly functioning CNS shunt or Ommaya reservoir. 9. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 with no deterioration over the previous 2 weeks. 10. Women of child-bearing potential and male subjects shall agree to take medically acceptable contraception measures while on study treatment and for 3 months following completion of study treatment. All women of child-bearing potential must have a negative blood pregnancy test at screening. 11. (a) For Patients with measurable CNS lesions must have AT LEAST ONE site of CNS lesion, which was not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter by MRI and which is suitable for accurate repeated measurements. Measurable extracranial disease is not required. (b) For Patients with non-measurable CNS lesions must have AT LEAST ONE extracranial lesion, which has not been previously irradiated, within the screening period that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) by CT/MRI and are suitable for accurate repeated measurement.

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Conditions

The condition(s) this trial relates to.

brain cancer lung neoplasm metastatic malignant neoplasm in the brain neoplasm non-small cell lung carcinoma respiratory system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain metastases EGFR gene mutation Non-small cell lung cancer

Contacts and locations

Locations

  • China site

    Hefei, Anhui, 230001, China

  • China site

    Chongqing, China, 400037, China

  • China site

    Fuzhou, Fujian, 350014, China

  • China site

    Xiamen, Fujian, 361003, China

  • China site

    Guangzhou, Guangdong, 510080, China

  • China site

    Guangzhou, Guangdong, 510180, China

  • China site

    Haerbin, Heilongjiang, 150081, China

  • China site

    Zhengzhou, Henan, 450008, China

  • China site

    Zhengzhou, Henan, 450052, China

  • China site

    Wuhan, Hubei, 430022, China

  • China site

    Wuhan, Hubei, 430030, China

  • China site

    Wuhan, Hubei, 430079, China

  • China site

    Yichang, Hubei, 443003, China

  • China site

    Changsha, Hunan, 410013, China

  • China site

    Nanjing, Jiangsu, 210002, China

  • China site

    Nanjing, Jiangsu, 210009, China

  • China site

    Suzhou, Jiangsu, 215004, China

  • China site

    Wuxi, Jiangsu, 214062, China

  • China site

    Xuzhou, Jiangsu, 221002, China

  • China site

    Yangzhou, Jiangsu, 225001, China

  • China site

    Changchun, Jilin, 130012, China

  • China site

    Changchun, Jilin, 130021, China

  • China site

    Xi'an, Shaanxi, 710061, China

  • China site

    Linyi, Shandong, 276000, China

  • China site

    Weifang, Shandong, 261000, China

  • China site

    Yantai, Shandong, 264000, China

  • China site

    Chengdu, Sichuan, 610041, China

  • China site

    Kunming, Yunnan, 650118, China

  • China site

    Hangzhou, Zhejiang, 310003, China

  • China site

    Hangzhou, Zhejiang, 310022, China

  • China site

    Hangzhou, Zhejiang, 311100, China

  • China site

    Beijing, 100021, China

  • China site

    Beijing, 100071, China

  • China site

    Beijing, 100142, China

  • China site

    Beijing, 100730, China

  • China site

    Chongqing, 400030, China

  • China site

    Chongqing, 400042, China

  • China site

    Shanghai, 200030, China

  • China site

    Shanghai, 200032, China

  • China site

    Tianjin, 300052, China

  • China site 0123

    Jinan, Shandong, 250117, China

  • Korea Site

    Seoul, 03080, South Korea

  • Korea Site

    Seoul, 06351, South Korea

  • Korea Site

    Taebuk, 28644, South Korea

  • Korea site

    Daegu, 42415, South Korea

  • Korea site

    Gyeonggi-do, 16247, South Korea

  • Korea site

    Gyeongsang, 52727, South Korea

  • Korea site

    Incheon, 21565, South Korea

  • Korea site

    Seoul, 05368, South Korea

  • Korea site

    Seoul, 06591, South Korea

  • Korea site

    Seoul, 07061, South Korea

  • Korea site

    Suwon, 16499, South Korea

  • Korea site

    Ulsan, 44033, South Korea

  • Singapore site

    Singapore, 308433, Singapore

  • Taiwan site

    Taichung, 407, Taiwan

  • Taiwan site

    Tainan, 704, Taiwan

  • Taiwan site

    Taipei, 100, Taiwan

  • Taiwan site

    Taoyuan, 333, Taiwan

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