CompletedPhase 1

Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer

China17 participantsStarted 2018-10-18

Plain-language summary

To explore the DLT of ZG0418 for Patients with Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib, and to determine the MTD or the R2PD.

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

. Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib
. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2.
. Life expectancy of at least 12 weeks.
. Ability to swallow and retain oral medication.
. Adequate organ system function, defined as follows:
. Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L
. Platelets ≥75 x 10\^9/L
. Hemoglobin ≥9 g/dL (≥90 g/L) Note that transfusions are allowed to meet the required hemoglobin level

Exclusion criteria

. chemotherapy, radiation therapy, immunotherapy within 4 weeks.
. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
. uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion.

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

MTD

Timeframe: Day1 to Day25

Trial details

NCT IDNCT03607188

SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-17

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