Squamous Cell Lung CancerPhase 2NCT03574818
Necitumumab in the Neoadjuvant Setting With Gemcitabine in Surgically Resectable - 14X-US-I001
A Phase 2 study testing Necitumumab-Gemcitabine-Cisplatin and Evaluation to determine if patient is a candidate to proceeed with surgical resection or not in people with Squamous Cell Lung Cancer, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This will be a single-arm study to primarily evaluate the feasibility of administering necitumumab added to gemcitabine and cisplatin as neoadjuvant treatment in treatment-naïve patients with stage IB (tumor size >4cm), II or IIIA squamous NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Lung Cancer
- What is being tested?
- Necitumumab-Gemcitabine-Cisplatin and Evaluation to determine if patient is a candidate to proceeed with surgical resection or not
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2018to 26 Sep 2019
- Phase
- Phase 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
- Patients must have histologically or cytologically confirmed squamous cell non-small cell lung cancer with any of the following stage groupings: IB with tumor size >4cm, II or potentially resectable IIIA.
- Patients who have been evaluated by thoracic surgery and eligible for resection.
- Patients must have adequate fresh frozen paraffin embedded (FFPE) tumor tissue available to perform pre-treatment biomarker testing.
- No prior systemic treatment for squamous cell non-small cell lung cancer.
- Age ≥18 years.
- ECOG performance status 0-1 (Karnofsky ≥70%, see Appendix A).
Show all 36Show fewer
- Patients must have hematologic function as defined by:
- absolute neutrophil count ≥1.5 x 109/L
- hemoglobin ≥9.0 g/dL
- platelets ≥100 x 109/L
- Patients must have organ function as defined below:
- bilirubin ≤1.5 × the upper limit of normal (ULN), alkaline phosphatase (ALP), alanine aminotransferase (ALT) and asparate transaminase (AST) ≤3.0 times ULN. For patients with hepatic metastases, ALT and AST equaling ≤5.0 times ULN are acceptable.
- If a patient experiences elevated ALT >5 × ULN and elevated total bilirubin >2 × ULN, clinical and laboratory monitoring should be initiated by the investigator. For patients entering the study with ALT >3 × ULN, monitoring should be triggered at ALT >2 × baseline.
- calculated creatinine clearance >50mL/min (per the Cockcroft-Gault formula).
- serum albumin ≥2.5 g/dL
- Patients may be on a stable regimen of therapeutic anticoagulation or may be receiving prophylactic anticoagulation of venous access devices.
- The patient is a woman of child-bearing potential who tests negative for pregnancy within 14 days prior to receiving first dose of study medication based on serum pregnancy test and agrees to use 2 methods of birth control or abstain from heterosexual activity during the study and for 6 months following the last dose of the study drug(s) or country requirements, whichever is longer or be of non-child bearing potential.
- Non-childbearing potential is defined as (by other than medical reasons):
- ≥45 years of age and has not had menses for greater than 2 years,
- amenorrheic for < 2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation, or
- post hysterectomy, oophorectomy or tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 6 months after the last dose of study therapy.
- Ability to understand and the willingness to sign a written informed consent document.
- The patient is willing to comply with protocol schedules and testing. -
- Exclusion Criteria: Patients with histologically or cytologically confirmed non-squamous cell, small cell or mixed histology lung carcinoma.
- Patients with stage IIIB or stage IV disease.
- Prior history of other malignancy, provided that he/she has been free of disease for ≥3 years, with the exception of in-situ carcinoma of the cervix or completely resected basal cell carcinoma of the skin.
- Patients who are receiving any other investigational agents.
- The patient has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab, or any other contraindication to one of the administered treatments.
- History or evidence of current clinically relevant coronary artery disease ≥ Grade III by the Canadian Cardiovascular Society Angina Grading Scale or uncontrolled congestive heart failure of current > Class III as defined by the New York Heart Association.
- The patient has experienced myocardial infarction within 6 months prior to study enrollment.
- The patient has any ongoing or active infection, including active tuberculosis or known infection with the human immunodeficiency virus.
- Recent (within 30 days before enrollment) or concurrent yellow fever vaccination.
- The patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment.
- History of arterial or venous thromboembolism within 3 months prior to study enrollment. Patients with a history of venous thromboembolism beyond 3 months prior to study enrollment can be enrolled if they are appropriately treated with low molecular weight heparin.
- The patient has any NCI-CTCAE Version 4.0 Grade ≥2 peripheral neuropathy.
- The patient has any other serious uncontrolled medical disorders or psychological conditions that would, in the opinion of the investigator, limit the patient's ability to complete the study or sign an informed consent document.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: A Feasibility and Biomarker Study to Evaluate Necitumumab in the Neoadjuvant Setting With Gemcitabine and Cisplatin in Surgically Resectable Squamous Lung Cancer
This will be a single-arm study to primarily evaluate the feasibility of administering necitumumab added to gemcitabine and cisplatin as neoadjuvant treatment in treatment-naïve patients with stage IB (tumor size >4cm), II or IIIA squamous NSCLC. Feasibility will be assessed by the proportion of patients able to proceed to surgery after administering necitumumab in the neoadjuvant setting. These patients would otherwise be offered standard adjuvant chemotherapy (without necitumumab) for squamous cell lung cancer. Determination of surgical resectability will be reviewed at a multidisciplinary thoracic tumor board, attended by surgical oncology, medical oncology, radiation oncology, radiology, and pathology.
Read the detailed description
The goal of this study is to explore whether it is possible to add a drug called necitumumab to standard treatment for patients with squamous cell lung cancer that can be surgically removed. This study is important because it will determine whether there is added benefit to giving necitumumab with chemotherapy before surgery. It is currently already known that chemotherapy given before or after surgery has better outcomes compared to only receiving surgery. Results from this study may help to develop more effective treatments for patients with squamous cell lung cancer.
The U.S. Food and Drug Administration (FDA) has approved necitumumab in combination with chemotherapy drugs called gemcitabine and cisplatin to treat stage IV or metastatic squamous cell lung cancer, but the FDA has not approved necitumumab to treat squamous cell lung cancer that can be surgically removed.
Analyzing the tumor cells from many cases of squamous cell lung cancer has shown that this cancer often has a special protein called EGFR. Necitumumab is a drug that targets EGFR.
Results from a recent medical study showed that patients with stage IV or metastatic squamous cell lung cancer who received necitumumab with gemcitabine and cisplatin showed a small, but significant, improvement in survival. We believe trying to gather more information about the way necitumumab interacts with cancer cells will help to learn how to use necitumumab more effectively.
This study will allow to see the effects of treating an earlier stage of squamous cell lung cancer using necitumumab with gemcitabine and cisplatin. It will also allow us to better analyze tumor cells after they have been treated with necitumumab and chemotherapy that are obtained after surgical resection. Other blood samples that will be drawn during the treatment will also allow to see the effect of necitumumab on both the body and the tumor cells and to observe any side effects that may result from this treatment.
- Conditions
- Squamous Cell Lung Cancer
- Being tested
- Necitumumab-Gemcitabine-Cisplatin, Evaluation to determine if patient is a candidate to proceeed with surgical resection or not
- Keywords
- Neoadjuvant Chemotherapy; NSCLC; nacitumumab
- 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.
Necitumumab-Gemcitabine-CisplatinDrug
Also called PORTRAZZA™ - GEMZAR™ - PLATINOL™
- Gemcitabine 1250mg/m2 IV on D1, D8
- Cisplatin 75mg / m2 IV on D1
- Necitumumab 800mg IV on D1, D8 (peripheral blood for effector cells and cytokine measurements prior to each cycle) Repeat cycle every 21 days up to 3 cycles.
Evaluation to determine if patient is a candidate to proceeed with surgical resection or notDiagnostic test
Patients will be evaluated with repeat imaging studies (PET/CT or CT Chest, Abdomen, Pelvis) and will be re-evaluated for surgical resection. Patients who had progressive disease or are NOT a surgical candidate will come off the study and will be treated according to standard therapies. All patients will be followed up for 2-year disease-free survival and overall survival
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Chemotherapy and Necitumumab Regimen Gemcitabine 1250mg/m2 IV over 30 minutes, days 1 and 8 following necitumumab, Cisplatin 75mg/m2 IV over 60 minutes, day 1, immediately following gemcitabine,each cycle is 3 weeks (21 days).
Necitumumab 800mg absolute dose IV over a minimum of 60 minutes, days 1 and 8 prior to chemotherapy regimen Each cycle is 3 weeks (21 days).
The regimen will be given for a total of 3 cycles.
The regimen will be given for a total of 3 cycles. Receives: Drug: Necitumumab-Gemcitabine-Cisplatin; Diagnostic Test: Evaluation to determine if patient is a candidate to proceeed with surgical resection or not |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgically Resectable
Patients able to proceed to surgery after administering necitumumab in the neoadjuvant setting with gemcitabine and cisplatin in surgically resectable patients with stage IB with tumor size >4cm, II and potentially resectable IIIA squamous cell lung cancer.
Measured: up to 63 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start29 May 2018
- Primary completion25 Oct 2018
- Study completion26 Sep 2019
Why it stopped: Poor accrual
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 Squamous Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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
- Model description
- Feasibility and Biomaker Study
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Balazs Halmos, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574818
- Sponsor's protocol ID
- 2017-8108
- Status last verified
- Mar 2020
- First submitted
- 24 Apr 2018
- Last updated
- 18 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility and Biomarker Study to Evaluate Necitumumab in the Neoadjuvant Setting With Gemcitabine and Cisplatin in Surgically Resectable Squamous Lung Cancer
- ClinicalTrials.gov ID
- NCT03574818
- Acronym / sponsor ID
- 2017-8108
- Conditions
- Squamous Cell Lung Cancer
- Keywords
- Neoadjuvant Chemotherapy; NSCLC; nacitumumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 29 May 2018 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Posted 18 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a single-arm study to primarily evaluate the feasibility of administering necitumumab added to gemcitabine and cisplatin as neoadjuvant treatment in treatment-naïve patients with stage IB (tumor size >4cm), II or IIIA squamous NSCLC. Feasibility will be assessed by the proportion of patients able to proceed to surgery after administering necitumumab in the neoadjuvant setting. These patients would otherwise be offered standard adjuvant chemotherapy (without necitumumab) for squamous cell lung cancer. Determination of surgical resectability will be reviewed at a multidisciplinary thoracic tumor board, attended by surgical oncology, medical oncology, radiation oncology, radiology, and pathology.
Detailed description
The goal of this study is to explore whether it is possible to add a drug called necitumumab to standard treatment for patients with squamous cell lung cancer that can be surgically removed. This study is important because it will determine whether there is added benefit to giving necitumumab with chemotherapy before surgery. It is currently already known that chemotherapy given before or after surgery has better outcomes compared to only receiving surgery. Results from this study may help to develop more effective treatments for patients with squamous cell lung cancer.
The U.S. Food and Drug Administration (FDA) has approved necitumumab in combination with chemotherapy drugs called gemcitabine and cisplatin to treat stage IV or metastatic squamous cell lung cancer, but the FDA has not approved necitumumab to treat squamous cell lung cancer that can be surgically removed.
Analyzing the tumor cells from many cases of squamous cell lung cancer has shown that this cancer often has a special protein called EGFR. Necitumumab is a drug that targets EGFR.
Results from a recent medical study showed that patients with stage IV or metastatic squamous cell lung cancer who received necitumumab with gemcitabine and cisplatin showed a small, but significant, improvement in survival. We believe trying to gather more information about the way necitumumab interacts with cancer cells will help to learn how to use necitumumab more effectively.
This study will allow to see the effects of treating an earlier stage of squamous cell lung cancer using necitumumab with gemcitabine and cisplatin. It will also allow us to better analyze tumor cells after they have been treated with necitumumab and chemotherapy that are obtained after surgical resection. Other blood samples that will be drawn during the treatment will also allow to see the effect of necitumumab on both the body and the tumor cells and to observe any side effects that may result from this treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility and Biomaker Study
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Necitumumab-Gemcitabine-Cisplatin, Diagnostic Test: Evaluation to determine if patient is a candidate to proceeed with surgical resection or notChemotherapy and Necitumumab Regimen Gemcitabine 1250mg/m2 IV over 30 minutes, days 1 and 8 following necitumumab, Cisplatin 75mg/m2 IV over 60 minutes, day 1, immediately following gemcitabine,each cycle is 3 weeks (21 days). Necitumumab 800mg absolute dose IV over a minimum of 60 minutes, days 1 and 8 prior to chemotherapy regimen Each cycle is 3 weeks (21 days). The regimen will be given for a total of 3 cycles. The regimen will be given for a total of 3 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Patients must have histologically or cytologically confirmed squamous cell non-small cell lung cancer with any of the following stage groupings: IB with tumor size >4cm, II or potentially resectable IIIA.
- Patients who have been evaluated by thoracic surgery and eligible for resection.
- Patients must have adequate fresh frozen paraffin embedded (FFPE) tumor tissue available to perform pre-treatment biomarker testing.
- No prior systemic treatment for squamous cell non-small cell lung cancer.
- Age ≥18 years.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Necitumumab-Gemcitabine-CisplatinAlso: PORTRAZZA™ - GEMZAR™ - PLATINOL™* Gemcitabine 1250mg/m2 IV on D1, D8 * Cisplatin 75mg / m2 IV on D1 * Necitumumab 800mg IV on D1, D8 (peripheral blood for effector cells and cytokine measurements prior to each cycle) Repeat cycle every 21 days up to 3 cycles. | Drug | Arm 1 |
| Evaluation to determine if patient is a candidate to proceeed with surgical resection or notPatients will be evaluated with repeat imaging studies (PET/CT or CT Chest, Abdomen, Pelvis) and will be re-evaluated for surgical resection. Patients who had progressive disease or are NOT a surgical candidate will come off the study and will be treated according to standard therapies. All patients will be followed up for 2-year disease-free survival and overall survival | Diagnostic test | Arm 1 |
Primary outcome
Surgically Resectable
Time frame: up to 63 days
Patients able to proceed to surgery after administering necitumumab in the neoadjuvant setting with gemcitabine and cisplatin in surgically resectable patients with stage IB with tumor size >4cm, II and potentially resectable IIIA squamous cell lung cancer.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Necitumumab-Gemcitabine-Cisplatin and Evaluation to determine if patient is a candidate to proceeed with surgical resection or not in people with Squamous Cell Lung Cancer, run by Montefiore Medical Center 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 36 inclusion and 0 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: stopped early, as of the sponsor's last update on 18 Mar 2020. 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 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?
Yes. Results are posted in the registry (first posted 18 Feb 2020). 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?
Surgically Resectable (time frame: up to 63 days). 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 18 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.