Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04165330 · ClinicalTrials.gov registry record · Phase 1
Evaluation of AL3818 in Combination With Nivolumab in Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Small-cell Lung Cancer, sponsored by Sarcoma Oncology Research Center.
- Active
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT04165330: Active Phase 1 study of Non-Small Cell Lung Cancer and Small-cell Lung Cancer, sponsored by Sarcoma Oncology Research Center.
NCT04165330 is a Phase 1 study of Non-Small Cell Lung Cancer and Small-cell Lung Cancer that is active but no longer recruiting, run by Sarcoma Oncology Research Center. The registered enrollment target is 56 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04165330, a Phase 1 study of Non-Small Cell Lung Cancer and Small-cell Lung Cancer, is active but no longer recruiting, sponsored by Sarcoma Oncology Research Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
This study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in combination with Opdivo (nivilumab) for the treatment patients with of metastatic, advanced, or recurrent solid tumors. All participants will receive open-label AL3818 with nivolumab. Part 1 consists of a dose finding phase to determine the recommended phase 2 dosage of AL3818 with nivolumab. Part 2 consists of a dose expansion phase, evaluating the safety and efficacy of the combination in patients cohorts including metastatic, advanced, or recurrent soft tissue sarcomas, non-small cell lung cancer, and small cell lung cancer.
Primary Outcome
Determine the Recommended Phase 2 Dose (RP2D) via evaluation of dose limiting toxicity (DLT) events.
Conditions Studied
Interventions
- DRUG AL3818
- DRUG Nivolumab Injection
Study Locations (1)
California
- Sarcoma Oncology Research Center - Santa Monica
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2019-10-17 |
| Est. Completion | 2028-03-31 |
| Phase | Phase 1 |
What the registry record for NCT04165330 still lists
NCT04165330 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (91% lower).
The record links to 4 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which AL3818 is the first listed.
NCT04165330 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04165330 about?
NCT04165330 is a clinical study titled "Evaluation of AL3818 in Combination With Nivolumab in Solid Tumors". This study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in combination with Opdivo (nivilumab) for the treatment patients with of metastatic, advanced, or recurrent solid tumors. All participants will receive open-label AL3818 with nivolumab. Part 1 consists of a dose findin...
What is the current status of trial NCT04165330?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2019-10-17. Estimated completion is 2028-03-31.
What conditions does trial NCT04165330 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Small-cell Lung Cancer, Solid Tumor, Adult, Soft Tissue Sarcoma.
What interventions are being tested in trial NCT04165330?
The interventions under investigation include: AL3818 (DRUG), Nivolumab Injection (DRUG).
Who is sponsoring clinical trial NCT04165330?
This trial is sponsored by Sarcoma Oncology Research Center, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04165330 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04165330's enrollment target sits among peer trials
56 323rd of 454 higher than 130 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers
RECRUITING · Phase 1
-
Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC
RECRUITING · Phase 1
-
A Study Investigating BG-60366 in Adults With Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
RECRUITING · Phase 1
-
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
RECRUITING · Phase 1
-
A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02287428 · 56 participants · Phase 1
Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM
- NCT02923011 · 56 participants · Phase 3
Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas
- NCT02935283 · 56 participants
Neuroimaging and Neuropsychological Outcomes in Urea Cycle Disorders
- NCT03375866 · 56 participants · NA
Effects of Mixed Nut Consumption on Satiety and Weight Management
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI