Phase 2 Lung Cancer Trial, Not Yet Recruiting NCT07283198 Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Not Yet Recruiting

NCT07283198
Not Yet Recruiting Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who are able to understand the consent form, choose to take part willingly, and sign the consent form.
  • People who are 18 years of age or older on the day they sign the consent form, of any gender.
  • People who have a performance status score of 0 or 1 on a standard scale used to measure how much a person's cancer affects their daily activities (confirm with trial site).
  • People whose doctors expect them to survive for at least 3 months.
  • People who have been confirmed through laboratory testing of tissue or cells to have locally advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiotherapy with the aim of curing the disease.
  • People whose NSCLC has been confirmed to not have other known gene changes for which a first-line targeted treatment has already been approved.
  • For Part 1 of the trial (Dose Selection): People with advanced NSCLC that cannot be removed by surgery, or that has spread, whose previous standard treatments have not worked or were not tolerated, and whose tumour tissue shows a HER2 mutation or HER2 expression.
  • For Part 2 of the trial (Cohort Expansion): People with locally advanced or metastatic NSCLC who have not yet received any systemic anti-cancer treatment for their advanced disease.
  • People who have at least one measurable area of cancer outside the brain at the start of the trial, as assessed by standard imaging criteria.
  • People who are able to provide a tumour tissue sample.
  • People whose organs (such as the liver, kidneys, and heart) are functioning well enough to meet the trial's requirements (confirm with trial site).
  • People who agree to use highly effective contraception from the time of signing the consent form until 24 weeks after the last dose — this applies to women who are able to become pregnant, and to men whose partners are able to become pregnant.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People whose lung cancer tissue is found to contain any small cell carcinoma component.
  • People who have had another type of cancer in the 5 years before starting the trial.
  • People who have a history of cancer spreading to the brainstem, the lining of the brain, or the spinal cord, or who currently have active brain metastases.
  • People whose scans during the screening period show that the tumour is growing into, pressing on, or located near vital surrounding organs.
  • People who have not waited long enough after previous treatments before starting the trial (confirm with trial site for specific timeframes).
  • People who have certain lung diseases or a history of conditions that cause serious breathing problems (confirm with trial site for specific conditions).
  • People who have risk factors related to a condition called interstitial lung disease or non-infectious lung inflammation (confirm with trial site for specific risk factors).
  • People who have certain heart or blood vessel diseases, or risk factors for these conditions (confirm with trial site for specific conditions).
  • People who currently have an infection that is not under control.
  • People who still have side effects from previous cancer treatment that have not improved to a mild level or resolved (based on a standard grading scale called CTCAE v5.0).
  • People who have previously received a bone marrow or organ transplant from another person.
  • People who are known to be allergic to any ingredient in the study drug.
  • Women who are pregnant, breastfeeding, or planning to become pregnant during the study.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 31 July 2026

Contact this trial

Phone: +86 731 8976 2300

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Registry
ClinicalTrials.gov
Start date
10 December 2025
Est. completion
30 August 2027

Primary endpoints

Number and Severity of Treatment-emergent Adverse Events (TEAEs); Objective response rate (ORR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov