Non-squamous Cell Non-Metastatic Non-Small Cell Lung CancerPhase 2NCT01860040
Neoadjuvant Chemo for Non-metastatic Non-small Cell Lung Cancer
A Phase 2 study testing Cisplatin, Pemetrexed and Gemcitabine in people with Non-squamous Cell Non-Metastatic Non-Small Cell Lung Cancer and Squamous Cell Non-Metastatic Non-Small Cell Lung Cancer, run by Western Regional Medical Center at 1 site in United States.
Trial summary
To determine the rate of pathologic complete responses (pCR) at the time of definitive surgical resection of 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-squamous Cell Non-Metastatic Non-Small Cell Lung Cancer, Squamous Cell Non-Metastatic Non-Small Cell Lung Cancer
- What is being tested?
- Cisplatin, Pemetrexed and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2016
- 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 ≥ 18 years of age with either a mass suspicious for or histologically confirmed AJCC stage IB-IIIA NSCLC. For those without histologic confirmation of NSCLC, a biopsy will be done and only those patients with histologically confirmed NSCLC meeting all other eligibility criteria may proceed on protocol.
- Mass must be determined to be surgically resectable
- Eastern Cooperative Oncology Group (ECOG) performance status score < 1 and a life expectancy >3 months.
- Participants must have at least one evaluable lesion as defined by RECIST 1.1
- Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL
- Serum creatinine ≤1.3 mg/dL (candidate for cisplatin chemotherapy), total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range
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- No prior chemotherapy or radiotherapy for NSCLC
- At least 5 years from diagnosis of another cancer except treated in-situ disease or surgically resected non-melanoma skin cancer with clear margins.
- Willingness to provide permission to biopsy NSCLC for collection of frozen pretreatment sample.
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial
Who cannot join
- Active clinically serious infection > CTCAE (version 4.03) Grade 2.
- Serious non-healing wound, ulcer, or bone fracture.
- Major contraindication to surgical resection of NSCLC
- Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
- Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
- Patients receiving any other investigational agents.
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Regional Medical Center
Goodyear, Arizona, 85338
About this study
Official title: Neoadjuvant Chemotherapy for Non-metastatic Non-small Cell Lung Cancer
To determine the rate of pathologic complete responses (pCR) at the time of definitive surgical resection of non-small cell lung cancer (NSCLC)
Read the detailed description
Participants in this study will have a lung mass and are undergoing a procedure to determine if they have non-small cell lung cancer that could be removed surgically. If confirmed to have non-small cell lung cancer that can be surgically removed, he or she may be able to continue as a possible participant in this study.
The purpose of this study is to determine whether neoadjuvant chemotherapy (chemotherapy that is given before surgery) will improve the amount of time a participant is free from disease in people with non-metastatic (has not spread from the original site) non-small cell lung cancer. The chemotherapy medications that will be used in this study are cisplatin and pemetrexed or cisplatin and gemcitabine and have been shown to be effective in patients with non-small cell lung cancer.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called Platinol®
Alkylating antineoplastic agent (Chemotherapy)
PemetrexedDrug
Also called Alimta®
Antimetabolite antineoplastic agent (Chemotherapy)
GemcitabineDrug
Also called Gemzar®
Antimetabolite antineoplastic agent (Chemotherapy)
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin and pemetrexed | Experimental | Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles Receives: Drug: Cisplatin; Drug: Pemetrexed |
| Cisplatin and gemcitabine | Experimental | Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles Receives: Drug: Cisplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Pathologic Complete Responses (pCR) at the Time of Definitive Surgical Resection of Non-small Cell Lung Cancer
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic Resonance Imagery (MRI): Complete Response (CR), Disappearance of all target lesions
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2014
- Study completionApr 2016
Why it stopped: Poor accrual, no data to analyze
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-squamous Cell Non-Metastatic 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glen Weiss, MD, Principal investigator, Western Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860040
- Sponsor's protocol ID
- 13-04
- Status last verified
- Jan 2018
- First submitted
- 17 May 2013
- Last updated
- 7 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy for Non-metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01860040
- Acronym / sponsor ID
- 13-04
- Conditions
- Non-squamous Cell Non-Metastatic Non-Small Cell Lung Cancer, Squamous Cell Non-Metastatic Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual, no data to analyze
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Western Regional Medical CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 May 2013 (estimated)
- Results
- Posted 25 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the rate of pathologic complete responses (pCR) at the time of definitive surgical resection of non-small cell lung cancer (NSCLC)
Detailed description
Participants in this study will have a lung mass and are undergoing a procedure to determine if they have non-small cell lung cancer that could be removed surgically. If confirmed to have non-small cell lung cancer that can be surgically removed, he or she may be able to continue as a possible participant in this study.
The purpose of this study is to determine whether neoadjuvant chemotherapy (chemotherapy that is given before surgery) will improve the amount of time a participant is free from disease in people with non-metastatic (has not spread from the original site) non-small cell lung cancer. The chemotherapy medications that will be used in this study are cisplatin and pemetrexed or cisplatin and gemcitabine and have been shown to be effective in patients with non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cisplatin and pemetrexed | Experimental | Drug: Cisplatin, Drug: PemetrexedCisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles |
| Cisplatin and gemcitabine | Experimental | Drug: Cisplatin, Drug: GemcitabineCisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients ≥ 18 years of age with either a mass suspicious for or histologically confirmed AJCC stage IB-IIIA NSCLC. For those without histologic confirmation of NSCLC, a biopsy will be done and only those patients with histologically confirmed NSCLC meeting all other eligibility criteria may proceed on protocol.
- Mass must be determined to be surgically resectable
- Eastern Cooperative Oncology Group (ECOG) performance status score < 1 and a life expectancy >3 months.
- Participants must have at least one evaluable lesion as defined by RECIST 1.1
- Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL
Key exclusion criteria (7 listed)
- Active clinically serious infection > CTCAE (version 4.03) Grade 2.
- Serious non-healing wound, ulcer, or bone fracture.
- Major contraindication to surgical resection of NSCLC
- Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
- Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
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 |
|---|---|---|
| CisplatinAlso: Platinol®Alkylating antineoplastic agent (Chemotherapy) | Drug | Cisplatin and gemcitabine, Cisplatin and pemetrexed |
| PemetrexedAlso: Alimta®Antimetabolite antineoplastic agent (Chemotherapy) | Drug | Cisplatin and pemetrexed |
| GemcitabineAlso: Gemzar®Antimetabolite antineoplastic agent (Chemotherapy) | Drug | Cisplatin and gemcitabine |
Primary outcome
Rate of Pathologic Complete Responses (pCR) at the Time of Definitive Surgical Resection of Non-small Cell Lung Cancer
Time frame: One year
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic Resonance Imagery (MRI): Complete Response (CR), Disappearance of all target lesions
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- 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.
Glen Weiss, MD principal investigator
Western Regional Medical Center
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 Cisplatin, Pemetrexed and Gemcitabine in people with Non-squamous Cell Non-Metastatic Non-Small Cell Lung Cancer and Squamous Cell Non-Metastatic Non-Small Cell Lung Cancer, run by Western Regional 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 10 inclusion and 7 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 7 Feb 2018. 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 25 Oct 2017). 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?
Rate of Pathologic Complete Responses (pCR) at the Time of Definitive Surgical Resection of Non-small Cell Lung Cancer (time frame: One year). 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 7 Feb 2018.