Not Authorised Therapeutic exploratory (Phase II) Small Cell Lung Cancer (SCLC) patients who need ≥2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage.

Evaluation of the safety and efficacy of the drug AL8326 in the post-first treatment of small cell lung cancer.

EU CTIS ID: 2023-509067-24-00

What this study is testing

To determine the optimal biological dose (OBD) based on efficacy and safety of each dosing group. ORR for all dosing groups and OBD group plus expansion cohort for = or >2nd line treatment of AL8326 for SCLC patients.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1. Male or female, 18 years of age or older. 2. ECOG performance status of 0 or 1. 3. Histologically or cytologically confirmed SCLC. 4. Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1. 5. Have a life expectancy of at least 3 months.

You likely can't join if

  • Serious, non-healing wound, ulcer or bone fracture Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels Clinically significant cardiovascular disease including uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to enrollment; New York Heart Association (NYHA) Grade II or greater congestive heart failure serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral vascular disease Hemoptysis within 3 months prior to enrollment Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there is an emergent or life-threatening medical condition that required it.

The study team makes the final eligibility decision.

Where it's taking place

  • United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.