Non-small Cell Lung CancerPhase 1/2NCT02898116
Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer
A Phase 1/2 study testing Ensartinib and Durvalumab in people with Non-small Cell Lung Cancer and Carcinoma, run by Ludwig Institute for Cancer Research at 1 site in United States.
Trial summary
This was a Phase 1/2, open-label, multicenter, single-arm study of combination therapy with ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor, and durvalumab, an anti-programmed cell death ligand 1 (PD-L1) antibody, in subjects with ALK-rearranged (ALK-positive) non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Carcinoma, NSCLC
- What is being tested?
- Ensartinib and Durvalumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2017to 4 Aug 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic confirmation of metastatic NSCLC. Subjects must have had confirmed ALK rearrangement as assessed by immunohistochemistry. Subjects may have had prior therapy with ALK inhibitors (other than ensartinib) or been ALK inhibitor naïve. ALK inhibitor naïve subjects were informed of the availability of approved ALK inhibitors.
- Measurable disease according to RECIST 1.1, defined as ≥ 1 lesion that could be accurately measured in ≥ 1 dimension (longest diameter to be recorded for non-lymph node lesions, shortest diameter to be recorded for lymph node lesions). Each lesion must have been ≥ 10 mm when measured by computed tomography, magnetic resonance imaging, or caliper measurement by clinical examination or ≥ 20 mm when measured by chest x-ray.
- Willing to provide a fresh pre-treatment biopsy; however, if subject was ALK inhibitor naïve, either archival or pre-treatment biopsy was acceptable.
- Asymptomatic subjects with surgically treated brain metastases must have been ≥ 14 days post surgery at the time of first dosing, while clinically stable with no requirement for steroids. Asymptomatic subjects with radiation-treated brain metastases may have entered the study immediately after completion of the radiation (and been off steroids, if applicable). Symptomatic subjects (those experiencing headache, seizure etc.), must have been relieved from all symptoms of their central nervous system disease, and must have completed radiation and been off steroids prior to first dosing (anti seizure medicine permitted).
- Laboratory parameters for vital functions should have been in the normal range. Laboratory abnormalities that were not clinically significant were generally permitted, except for the following laboratory parameters, which must have been within the ranges specified, regardless of clinical significance:
- Hemoglobin: ≥ 9 g/dL
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- Neutrophil count: ≥ 1.5 x 10^9/L
- Platelet count: ≥ 100,000/mm^3
- Serum creatinine: ≤ 1.5 x institutional upper limit of normal (ULN), OR creatinine clearance: ≥ 50 mL/min (by Cockcroft-Gault formula)
- Serum total bilirubin: ≤ 1.5 × ULN (except for subjects with Gilbert's syndrome who were allowed after consultation with their physician)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT): ≤ 2.5 x ULN
- Alkaline phosphatase: ≤ 2.5 x ULN
- Eastern Cooperative Oncology Group Performance Status ≤ 2.
- Age ≥ 18 years.
- Able and willing to provide valid written informed consent.
- Able and willing to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up.
- Body weight > 30 kg.
Who cannot join
- Treatment with an investigational agent within 4 weeks of starting treatment, and any prior drug-related toxicity (except alopecia) should have recovered to Grade 1 or less.
- Prior treatment with anti-PD-1, PD-L1 (including durvalumab), or cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), or ensartinib (X-396).
- Active, suspected or prior documented autoimmune disease (including but not restricted to inflammatory bowel disease, celiac disease, Wegner's granulomatosis, Hashimoto's thyroiditis, rheumatoid arthritis, systemic lupus, scleroderma and its variants, multiple sclerosis, myasthenia gravis). Vitiligo, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger were permitted.
- Subjects with clinically significant cardiovascular disease, including:
- New York Heart Association Class II or higher congestive heart failure.
- Myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack within 6 months of start of study drug (Day -28).
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- Clinically significant supraventricular or ventricular arrhythmia.
- QT interval corrected using Fridericia's formula (QTcF) ≥ 450 ms (male) or QTcF ≥ 470 ms (female).
- Clinically uncontrolled hypertension.
- History of pneumonitis or interstitial lung disease, or any unresolved immune-related adverse events following prior therapy.
- Major surgery within 4 weeks of starting treatment (or scheduled for surgery during the projected course of the study).
- Women of child bearing potential who were pregnant as evidenced by positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) or nursing.
- Female subjects of childbearing potential who were sexually active with a non-sterilized male partner must have used at least one highly effective method of contraception (see table below) from the time of screening and must have agreed to continue using such precautions for 90 days after the final dose of investigational products. Non-sterilized male partners of a female subject must have used male condoms plus spermicide throughout this period. Cessation of birth control after this point should have been discussed with a responsible physician. Not engaging in sexual activity for the total duration of the trial and the drug washout period was an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method were not acceptable methods of birth control.
- Female subjects should have refrained from breastfeeding throughout the period described above.
- Females of childbearing potential were defined as those who were not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or post-menopausal.
- Females were considered post-menopausal if they had been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements applied:
- Females <50 years of age were considered post-menopausal if they had been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they had luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- Females ≥50 years of age were considered post-menopausal if they had been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year prior to study entry, had chemotherapy-induced menopause with last menses >1 year prior to study entry, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- Non-sterilized male subjects who were sexually active with a female partner of childbearing potential must have used male condoms plus spermicide from screening through 90 days after receipt of the final dose of investigational products. Male subjects were to refrain from sperm donation throughout this period. Female partners (of childbearing potential) of a male subject must have used a highly effective method of contraception (see table below) throughout this period. Cessation of birth control after this point was to be discussed with a responsible physician. Not engaging in sexual activity for the total duration of the trial and the drug washout period was an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method were not acceptable methods of birth control.
- A highly effective method of contraception was defined as one that resulted in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Note that some contraception methods were not considered highly effective (e.g. male or female condom with or without spermicide; female cap, diaphragm, or sponge with or without spermicide; non-copper containing intrauterine device; progestogen-only oral hormonal contraceptive pills where inhibition of ovulation was not the primary mode of action [excluding Cerazette/desogestrel which was considered highly effective]; and triphasic combined oral contraceptive pills).
- Subjects who were immunosuppressed, including those with known immunodeficiency.
- Active infection including tuberculosis (clinical evaluation that included clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive hepatitis B virus surface antigen result), hepatitis C, or human immunodeficiency virus (positive 1/2 antibodies). Subjects with a past or resolved hepatitis B virus infection (defined as the presence of hepatitis B core antibody and absence of hepatitis B virus surface antigen) were eligible. Subjects positive for hepatitis C antibody were eligible only if polymerase chain reaction was negative for hepatitis C virus ribonucleic acid.
- History of severe allergic reactions to any unknown allergens or components of the study drugs.
- Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).
- Mental impairment that may have compromised compliance with the requirements of the study.
- Lack of availability for immunological and clinical follow-up assessment.
- Inability to swallow or retain oral medication, presence of active gastrointestinal disease or other condition that would have interfered significantly with the absorption, distribution, metabolism, or excretion of ensartinib.
- Any condition that, in the clinical judgment of the treating physician, was likely to prevent the subject from complying with any aspect of the protocol or that may have put the subject at unacceptable risk.
- History of allogeneic organ transplant.
- Subjects must not have donated blood while on study and for at least 90 days following the last durvalumab treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1/2 Study of ALK Inhibitor, Ensartinib (X-396), and Anti-PD-L1, Durvalumab (MEDI4736), in Subjects With ALK-rearranged (ALK-positive) Non-small Cell Lung Cancer (NSCLC)
This was a Phase 1/2, open-label, multicenter, single-arm study of combination therapy with ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor, and durvalumab, an anti-programmed cell death ligand 1 (PD-L1) antibody, in subjects with ALK-rearranged (ALK-positive) non-small cell lung cancer (NSCLC). Primary study objectives were to determine the recommended combination dose (RCD) and safety and tolerability of the combination. Further objectives were to evaluate the clinical efficacy and biologic activity of the combination.
Read the detailed description
Prior to initiation of combination therapy with ensartinib plus durvalumab, subjects were enrolled sequentially to receive ensartinib monotherapy (orally once daily) during a pre-immunotherapy Run-in Period for one to two 28-day cycles. The purpose of the Run-in Period was to determine whether any safety signals might compromise combination therapy and to determine the effect of ALK inhibitor therapy on the immune tumor microenvironment. For subjects with no dose-limiting toxicity (DLT) during the Run-in Period, combination therapy was then initiated during a dose-finding phase using a standard 3 + 3 design until determination of the RCD, which was defined as the highest dose level at which ≤ 1 of 6 subjects (i.e., < 33%) experienced DLTs during the first 2 cycles of combination treatment.
A fixed dose of durvalumab (1500 mg by intravenous [IV] infusion every 4 weeks) was administered in all cohorts. Ensartinib dosing started at 200 mg, with subsequent cohorts receiving a reduced (150 mg) or escalated (225 mg) ensartinib dose depending upon observed toxicity. The study was then designed to include an expansion phase, in which the RCD cohort would be expanded to a total of 20 subjects.
Subjects were monitored for safety (including immune-related adverse events), disease status (using the Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1 and immune-related RECIST), and biologic activity (peripheral blood assays and immunological changes in the tumor microenvironment) for the duration of study participation.
- Conditions
- Non-small Cell Lung Cancer, Carcinoma, NSCLC
- Being tested
- Ensartinib, Durvalumab
- Keywords
- ALK-rearranged, ALK-positive, ALK Inhibitor, Ensartinib, X-396, anti-PD-L1, Durvalumab, MEDI4736, ALK
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnsartinibDrug
Also called X-396
Ensartinib was administered orally once daily at a dose of 200 mg during the Run-in Period. During combination therapy, the ensartinib starting dose was to be 200 mg. Based on observed toxicity at the starting dose level, the ensartinib dose may have been escalated to the recommended single-agent dose (225 mg) or de-escalated to the minimum effective dose (150 mg).
DurvalumabDrug
Also called MEDI4736
During combination therapy, durvalumab was to be administered as an IV infusion over 60 (± 5) minutes every 4 weeks at a dose of 1500 mg.
| Study group | Role | What they receive |
|---|---|---|
| Ensartinib ± Durvalumab | Experimental | Subjects were to receive ensartinib monotherapy during a pre-immunotherapy Run-in Period for one to two 28-day cycles, followed by combination therapy with ensartinib plus durvalumab for subjects with no DLTs during the Run-in Period. Receives: Drug: Ensartinib; Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Treatment-emergent Adverse Events
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the end of the study period. Dose-limiting toxicity (DLT) during the Run-in Period was defined as ≥ Grade 2 rash or other toxicity requiring discontinuation of ensartinib dosing.
Measured: up to 3 months
Secondary outcomes (2)
Number of Subjects With Best Overall Tumor Response at the Last Assessment
Tumor response was evaluated using computed tomography and categorized according to the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) at Baseline, every 2 cycles, and at the end of the study. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.
Measured: up to 3 months
Number of Subjects With Immune-related Tumor Response at the Last Assessment
Immune-related tumor response was evaluated by computed tomography at Baseline, every 2 cycles, and at the end of the study. Tumor response was designated according to the immune-related Response Criteria (irRC) (Wolchok et al. Clin Cancer Res 2009;15:7412-20) into the following categories: immune-related complete response (irCR) requires disappearance of all lesions in two consecutive observations not less than 4 weeks apart; immune-related partial response (irPR) requires ≥ 50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart; immune-related stable disease (irSD) is assigned when neither a 50% decrease from baseline tumor burden nor a 25% increase in tumor burden from nadir can be established; immune-related progressive disease (irPD) requires a ≥ 25% increase from nadir in tumor burden at any single time point in two consecutive observations at least 4 weeks apart.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start10 May 2017
- Primary completion4 Aug 2017
- Study completion4 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig Institute for Cancer Research
- Sponsor type
- University, hospital or other
- Collaborators
- MedImmune LLC, Xcovery Holdings, Inc., Cancer Research Institute, New York City
- Responsible party
- Sponsor
- Investigators
- Leena Gandhi, MD, PhD, Study chair, Laura & Isaac Perlmutter Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898116
- Sponsor's protocol ID
- LUD2014-012-ALK
- Status last verified
- Oct 2022
- First submitted
- 8 Sep 2016
- Last updated
- 10 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of ALK Inhibitor, Ensartinib (X-396), and Anti-PD-L1, Durvalumab (MEDI4736), in Subjects With ALK-rearranged (ALK-positive) Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT02898116
- Acronym / sponsor ID
- LUD2014-012-ALK
- Conditions
- Non-small Cell Lung Cancer, Carcinoma, NSCLC
- Keywords
- ALK-rearranged, ALK-positive, ALK Inhibitor, Ensartinib, X-396, anti-PD-L1, Durvalumab, MEDI4736
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Ludwig Institute for Cancer ResearchUniversity, hospital or other
- Collaborators
- MedImmune LLC, Xcovery Holdings, Inc., Cancer Research Institute, New York City
- Study start
- 10 May 2017 (actual)
- Primary completion
- 4 Aug 2017 (actual)
- Study completion
- 4 Aug 2017 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Posted 21 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a Phase 1/2, open-label, multicenter, single-arm study of combination therapy with ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor, and durvalumab, an anti-programmed cell death ligand 1 (PD-L1) antibody, in subjects with ALK-rearranged (ALK-positive) non-small cell lung cancer (NSCLC). Primary study objectives were to determine the recommended combination dose (RCD) and safety and tolerability of the combination. Further objectives were to evaluate the clinical efficacy and biologic activity of the combination.
Detailed description
Prior to initiation of combination therapy with ensartinib plus durvalumab, subjects were enrolled sequentially to receive ensartinib monotherapy (orally once daily) during a pre-immunotherapy Run-in Period for one to two 28-day cycles. The purpose of the Run-in Period was to determine whether any safety signals might compromise combination therapy and to determine the effect of ALK inhibitor therapy on the immune tumor microenvironment. For subjects with no dose-limiting toxicity (DLT) during the Run-in Period, combination therapy was then initiated during a dose-finding phase using a standard 3 + 3 design until determination of the RCD, which was defined as the highest dose level at which ≤ 1 of 6 subjects (i.e., < 33%) experienced DLTs during the first 2 cycles of combination treatment.
A fixed dose of durvalumab (1500 mg by intravenous [IV] infusion every 4 weeks) was administered in all cohorts. Ensartinib dosing started at 200 mg, with subsequent cohorts receiving a reduced (150 mg) or escalated (225 mg) ensartinib dose depending upon observed toxicity. The study was then designed to include an expansion phase, in which the RCD cohort would be expanded to a total of 20 subjects.
Subjects were monitored for safety (including immune-related adverse events), disease status (using the Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1 and immune-related RECIST), and biologic activity (peripheral blood assays and immunological changes in the tumor microenvironment) for the duration of study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ensartinib ± Durvalumab | Experimental | Drug: Ensartinib, Drug: DurvalumabSubjects were to receive ensartinib monotherapy during a pre-immunotherapy Run-in Period for one to two 28-day cycles, followed by combination therapy with ensartinib plus durvalumab for subjects with no DLTs during the Run-in Period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologic confirmation of metastatic NSCLC. Subjects must have had confirmed ALK rearrangement as assessed by immunohistochemistry. Subjects may have had prior therapy with ALK inhibitors (other than ensartinib) or been ALK inhibitor naïve. ALK inhibitor naïve subjects were informed of the availability of approved ALK inhibitors.
- Measurable disease according to RECIST 1.1, defined as ≥ 1 lesion that could be accurately measured in ≥ 1 dimension (longest diameter to be recorded for non-lymph node lesions, shortest diameter to be recorded for lymph node lesions). Each lesion must have been ≥ 10 mm when measured by computed tomography, magnetic resonance imaging, or caliper measurement by clinical examination or ≥ 20 mm when measured by chest x-ray.
- Willing to provide a fresh pre-treatment biopsy; however, if subject was ALK inhibitor naïve, either archival or pre-treatment biopsy was acceptable.
- Asymptomatic subjects with surgically treated brain metastases must have been ≥ 14 days post surgery at the time of first dosing, while clinically stable with no requirement for steroids. Asymptomatic subjects with radiation-treated brain metastases may have entered the study immediately after completion of the radiation (and been off steroids, if applicable). Symptomatic subjects (those experiencing headache, seizure etc.), must have been relieved from all symptoms of their central nervous system disease, and must have completed radiation and been off steroids prior to first dosing (anti seizure medicine permitted).
- Laboratory parameters for vital functions should have been in the normal range. Laboratory abnormalities that were not clinically significant were generally permitted, except for the following laboratory parameters, which must have been within the ranges specified, regardless of clinical significance:
Key exclusion criteria (30 listed)
- Treatment with an investigational agent within 4 weeks of starting treatment, and any prior drug-related toxicity (except alopecia) should have recovered to Grade 1 or less.
- Prior treatment with anti-PD-1, PD-L1 (including durvalumab), or cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), or ensartinib (X-396).
- Active, suspected or prior documented autoimmune disease (including but not restricted to inflammatory bowel disease, celiac disease, Wegner's granulomatosis, Hashimoto's thyroiditis, rheumatoid arthritis, systemic lupus, scleroderma and its variants, multiple sclerosis, myasthenia gravis). Vitiligo, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger were permitted.
- Subjects with clinically significant cardiovascular disease, including:
- History of pneumonitis or interstitial lung disease, or any unresolved immune-related adverse events following prior therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnsartinibAlso: X-396Ensartinib was administered orally once daily at a dose of 200 mg during the Run-in Period. During combination therapy, the ensartinib starting dose was to be 200 mg. Based on observed toxicity at the starting dose level, the ensartinib dose may have been escalated to the recommended single-agent dose (225 mg) or de-escalated to the minimum effective dose (150 mg). | Drug | Ensartinib ± Durvalumab |
| DurvalumabAlso: MEDI4736During combination therapy, durvalumab was to be administered as an IV infusion over 60 (± 5) minutes every 4 weeks at a dose of 1500 mg. | Drug | Ensartinib ± Durvalumab |
Primary outcome
Number of Subjects With Treatment-emergent Adverse Events
Time frame: up to 3 months
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the end of the study period. Dose-limiting toxicity (DLT) during the Run-in Period was defined as ≥ Grade 2 rash or other toxicity requiring discontinuation of ensartinib dosing.
2 secondary outcomes
Number of Subjects With Best Overall Tumor Response at the Last Assessment
Time frame: up to 3 months
Number of Subjects With Immune-related Tumor Response at the Last Assessment
Time frame: up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leena Gandhi, MD, PhD study chair
Laura & Isaac Perlmutter Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ensartinib and Durvalumab in people with Non-small Cell Lung Cancer and Carcinoma, run by Ludwig Institute for Cancer Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Treatment-emergent Adverse Events (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.