Non-Small Cell Lung Cancer StagePhase 2NCT03480230
Neoadjuvant Compound 121564 Plus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer
A Phase 2 study testing Compound 121564 in people with Non-Small Cell Lung Cancer Stage, run by Arafat Tfayli at 5 sites in 2 countries.
Trial summary
The purpose of this study is to assess the response rate to neoadjuvant Compound 121564 plus platinum doublet chemotherapy in patients with early stage non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer Stage
- What is being tested?
- Compound 121564
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 26 Jun 2018to Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Males and females aged ≥ 18 years.
- Histologically confirmed NSCLC (squamous and non-squamous).
- High-risk stage IB (tumor ≥ 4 cm in size, or grade 3, or with visceral pleura involvement), II or IIIA disease.
- Have biopsy tissue available (fresh and archived) for PD-L1 and correlative studies testing prior to therapy.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- 1. 6) Have a life expectancy of ≥ 6 months. 7) No previous systemic anticancer therapy or surgical resection for his or her NSCLC. 8) Subject has voluntarily agreed to participate by giving written informed consent for the trial. 9) Subject must be willing and able to comply with scheduled visits, treatment schedule and laboratory testing. 10) Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to receiving the first dose of study medication. 11) Females should not be breastfeeding. 12) Female subjects of childbearing potential as well as males sexually active with women of childbearing potential must be willing to use an adequate method of contraception. 13) Have pulmonary and cardiac function testing deemed adequate for thoracic surgical intervention. 14) Have adequate organ function by meeting the following:
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- Absolute neutrophil count (ANC) ≥1,500/mcL.
- Platelets ≥100,000/mcL.
- Hemoglobin ≥9 g/dL.
- Serum creatinine ≤1.5 X upper limit of normal (ULN) OR calculated creatinine clearance (CrCl) (GFR can also be used in place of creatinine or CrCl) ≥60 mL/min for subjects with creatinine levels > 1.5 X institutional ULN.
- Serum total bilirubin ≤ ULN.
- AST (SGOT) and ALT (SGPT) ≤ 1.5 X ULN.
- Alkaline phosphatase ≤ 2.5 X ULN.
- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy.
- Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy.
Who cannot join
- Subject deemed unfit for surgery (by pulmonary or cardiac assessment).
- Subject with known autoimmune disease that has required systemic therapy in the last 2 years.
- Prior organ transplantation including allogenic stem-cell transplantation.
- Clinically significant (i.e. active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
- Subject on immunosuppressive therapy or corticosteroids within 14 days prior to starting study drugs.
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- Subject with interstitial lung disease that is symptomatic or history of pneumonitis that required oral or systemic glucocorticoids to manage.
- Subject must have recovered from the effects of major surgery or significant trauma at least 14 days prior to therapy.
- Subject with previous malignancies are excluded unless complete remission was achieved at least 2 years prior to therapy.
- Other active malignancy requiring concurrent intervention.
- Subject with active infection requiring systemic therapy.
- Subject with known history of testing positive for human immunodeficiency virus (HIV) or known to have acquired immunodeficiency syndrome (AIDS).
- Subject has known active hepatitis B or C.
- Vaccination within 4 weeks of the first dose of Compound 121564 and while on trials is prohibited except for administration of inactivated vaccines.
- Subject is pregnant or breastfeeding.
- Subject has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Subject previously had a severe hypersensitivity reaction to any of the study drugs.
- Subject is currently participating and receiving study therapy from another clinical trial.
- Subject had prior treatment with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms.
- Patient who is not willing to sign the consent form.
- Legal incapacity or limited legal capacity patients receiving other oncology specific medication not authorized in the protocol.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Lebanon4 sites, 4 recruiting
- Recruiting
American University of Beirut Medical Center
Beirut
Arafat H Tfayli, MD, +961 1 350 000 ext. 7986, at35@aub.edu.lb
- Not yet recruiting
Bellevue Medical Center
Beirut
Fadi Karak, MD, +961 1 682 666 ext. 5620, elkarak@yahoo.com
- Recruiting
Lebanese American University Medical Center-Rizk Hospital
Beirut
Hady Ghanem, MD, +961 76 477 647 ext. 5414
- Not yet recruiting
Hammoud Hospital University Medical Center
Sidon
Fadi Farhat, MD, +961 7 723 111 ext. 1141, drfadi.clinic@gmail.com; drfadi.research@gmail.com
Jordan1 site, 1 recruiting
- Not yet recruiting
King Hussein Cancer Center
Amman
Taher Abu-Hejleh, MD, +962 6 53 00 460, ta.11703@khcc.jo
About this study
Official title: Phase II Trial of Neoadjuvant Compound 121564 Plus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer
The purpose of this study is to assess the response rate to neoadjuvant Compound 121564 plus platinum doublet chemotherapy in patients with early stage non-small cell lung cancer.
Read the detailed description
Open-label, single-arm multi-center phase II trial of neoadjuvant Compound 121564 plus platinum doublet chemotherapy conducted among patients with early stage (IB, II, IIIA) non-small cell lung cancer.
- Conditions
- Non-Small Cell Lung Cancer Stage
- Being tested
- Compound 121564
- Keywords
- Non-small cell lung cancer, Platinum doublet chemotherapy, Neoadjuvant
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound 121564Drug
Compound 121564 10 mg/Kg administered over 60 minutes given intravenously every 2 weeks for 4 doses plus chemotherapy depending on tumor histology.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | 1. Non-squamous histology:
* Compound 121564 10 mg/Kg administered over 60 minutes given intravenously every 2 weeks for 4 doses.
* Compound 565994 500 mg/m2 administered over 10 minutes, and
* Compound 232673 AUC=5 mg/mL/min administered over 15-60 minutes or Compound 454893 at 75 mg/m2 over 1 hour.
* Compound 565994 and platinum are to be given on day 1 of every 3-week cycle for 3 cycles.
2. Squamous histology:
* Compound 121564 10 mg/Kg administered over 60 minutes every 2 weeks for 4 doses.
* Compound 232673 AUC=5 mg/mL/min administered over 15-60 minutes or Compound 454893 at 75 mg/m2 over 1 hour on day 1 of every cycle.
* Compound 343782 1,000 mg/m2 administered over 30 minutes on days 1 and 8 of each cycle.
* Platinum and Compound 343782 will be given for 3 cycles. Receives: Drug: Compound 121564 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria
To assess the overall response rate (ORR) of patients receiving neoadjuvant Compound 121564 plus platinum doublet chemotherapy based on RECIST 1.1 criteria
Measured: At week 9
Secondary outcomes (12)
Pathologic complete response rate
To assess the pathologic complete response rate in patients receiving combination Compound 121564 and chemotherapy.
Measured: At 12 weeks
Major pathologic response rate (<10% viable tumor cells)
To assess the major pathologic response rate (<10% viable tumor cells) in patients receiving combination Compound 121564 and chemotherapy.
Measured: At 12 weeks
Progression-Free Survival (PFS)
To assess progression-free survival (PFS) at 1, 2 and 3 years in patients receiving a combination of Compound 121564 plus platinum doublet chemotherapy.
Measured: At 1, 2 and 3 years
Overall Survival (OS)
To assess overall survival (OS) in patients receiving a combination of Compound 121564 plus platinum doublet chemotherapy.
Measured: At 1, 2 and 3 years
Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria in enrolled squamous vs. non-squamous lung cancer patients
To compare the ORR in enrolled squamous vs. non-squamous lung cancer patients receiving the proposed treatment regimen.
Measured: At week 9
Progression-Free Survival (PFS) in enrolled squamous vs. non-squamous lung cancer patients
To compare the PFS in enrolled squamous vs. non-squamous lung cancer patients receiving the proposed treatment regimen.
Measured: At 1, 2 and 3 years
Overall Survival (OS) in enrolled squamous vs. non-squamous lung cancer patients
To compare the OS in enrolled squamous vs. non-squamous lung cancer patients receiving the proposed treatment regimen.
Measured: At 1, 2 and 3 years
Patient-related outcomes Quality of Life assessment using the questionnaire for functional assessment of cancer therapy for patients with lung cancer (FACT-L version 4)
To assess patient-related outcomes in patients receiving a combination of Compound 121564 plus platinum doublet chemotherapy.
Measured: At week 9
Number of participants with treatment-related adverse events as assessed by CTCAE v 4.0
To assess the tolerability of the proposed treatment regimen in the cohort of patient enrolled.
Measured: With every administration
Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria in patients with 50% or more PD-L1 vs. patients with less than 50% PD-L1
To analyze as exploratory analysis the ORR in patients with 50% or more PD-L1 expression level vs. patients with less than 50% PD-L1 expression level receiving the proposed treatment regimen.
Measured: At week 9
Progression-Free Survival (PFS) in patients with 50% or more PD-L1 vs. patients with less than 50% PD-L1
To analyze as exploratory analysis the PFS in patients with 50% or more PD-L1 expression level vs. patients with less than 50% PD-L1 expression level receiving the proposed treatment regimen.
Measured: At 1, 2 and 3 years
Overall Survival (OS) in patients with 50% or more PD-L1 vs. patients with less than 50% PD-L1
To analyze as exploratory analysis the OS in patients with 50% or more PD-L1 expression level vs. patients with less than 50% PD-L1 expression level receiving the proposed treatment regimen.
Measured: At 1, 2 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start26 Jun 2018
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer StageStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arafat Tfayli
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany, Phoenix Clinical Research
- Responsible party
- Sponsor-investigator, Arafat Tfayli, American University of Beirut Medical Center
- Investigators
- Arafat H Tfayli, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480230
- Sponsor's protocol ID
- BIO-2017-0467
- Other IDs
- MS100070_0020
- Status last verified
- Aug 2018
- First submitted
- 14 Mar 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Neoadjuvant Compound 121564 Plus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03480230
- Acronym / sponsor ID
- BIO-2017-0467
- Conditions
- Non-Small Cell Lung Cancer Stage
- Keywords
- Non-small cell lung cancer, Platinum doublet chemotherapy, Neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Arafat TfayliUniversity, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany, Phoenix Clinical Research
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the response rate to neoadjuvant Compound 121564 plus platinum doublet chemotherapy in patients with early stage non-small cell lung cancer.
Detailed description
Open-label, single-arm multi-center phase II trial of neoadjuvant Compound 121564 plus platinum doublet chemotherapy conducted among patients with early stage (IB, II, IIIA) non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Compound 1215641. Non-squamous histology: * Compound 121564 10 mg/Kg administered over 60 minutes given intravenously every 2 weeks for 4 doses. * Compound 565994 500 mg/m2 administered over 10 minutes, and * Compound 232673 AUC=5 mg/mL/min administered over 15-60 minutes or Compound 454893 at 75 mg/m2 over 1 hour. * Compound 565994 and platinum are to be given on day 1 of every 3-week cycle for 3 cycles. 2. Squamous histology: * Compound 121564 10 mg/Kg administered over 60 minutes every 2 weeks for 4 doses. * Compound 232673 AUC=5 mg/mL/min administered over 15-60 minutes or Compound 454893 at 75 mg/m2 over 1 hour on day 1 of every cycle. * Compound 343782 1,000 mg/m2 administered over 30 minutes on days 1 and 8 of each cycle. * Platinum and Compound 343782 will be given for 3 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Males and females aged ≥ 18 years.
- Histologically confirmed NSCLC (squamous and non-squamous).
- High-risk stage IB (tumor ≥ 4 cm in size, or grade 3, or with visceral pleura involvement), II or IIIA disease.
- Have biopsy tissue available (fresh and archived) for PD-L1 and correlative studies testing prior to therapy.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤
Key exclusion criteria (21 listed)
- Subject deemed unfit for surgery (by pulmonary or cardiac assessment).
- Subject with known autoimmune disease that has required systemic therapy in the last 2 years.
- Prior organ transplantation including allogenic stem-cell transplantation.
- Clinically significant (i.e. active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
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 |
|---|---|---|
| Compound 121564Compound 121564 10 mg/Kg administered over 60 minutes given intravenously every 2 weeks for 4 doses plus chemotherapy depending on tumor histology. | Drug | Treatment arm |
Primary outcome
Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria
Time frame: At week 9
To assess the overall response rate (ORR) of patients receiving neoadjuvant Compound 121564 plus platinum doublet chemotherapy based on RECIST 1.1 criteria
12 secondary outcomes
Pathologic complete response rate
Time frame: At 12 weeks
Major pathologic response rate (<10% viable tumor cells)
Time frame: At 12 weeks
Progression-Free Survival (PFS)
Time frame: At 1, 2 and 3 years
Overall Survival (OS)
Time frame: At 1, 2 and 3 years
Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria in enrolled squamous vs. non-squamous lung cancer patients
Time frame: At week 9
Progression-Free Survival (PFS) in enrolled squamous vs. non-squamous lung cancer patients
Time frame: At 1, 2 and 3 years
Overall Survival (OS) in enrolled squamous vs. non-squamous lung cancer patients
Time frame: At 1, 2 and 3 years
Patient-related outcomes Quality of Life assessment using the questionnaire for functional assessment of cancer therapy for patients with lung cancer (FACT-L version 4)
Time frame: At week 9
Number of participants with treatment-related adverse events as assessed by CTCAE v 4.0
Time frame: With every administration
Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria in patients with 50% or more PD-L1 vs. patients with less than 50% PD-L1
Time frame: At week 9
Progression-Free Survival (PFS) in patients with 50% or more PD-L1 vs. patients with less than 50% PD-L1
Time frame: At 1, 2 and 3 years
Overall Survival (OS) in patients with 50% or more PD-L1 vs. patients with less than 50% PD-L1
Time frame: At 1, 2 and 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Arafat H Tfayli, MD principal investigator
American University of Beirut Medical Center
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Compound 121564 in people with Non-Small Cell Lung Cancer Stage, run by Arafat Tfayli at 5 sites in 2 countries.
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 15 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Lebanon, Jordan. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arafat H Tfayli, MD (+961 1 350 000 ext. 7986, at35@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria (time frame: At week 9). 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 14 Aug 2018; AzTrials last refreshed its copy on 4 Nov 2026.