Stage IB Non-Small Cell Lung Carcinoma AJCC v7Phase 1NCT02225405
Cisplatin, Docetaxel, and Nintedanib Before Surgery in Treating Patients With Previously Untreated Stage IB-IIIA Non-small Cell Lung Cancer
A Phase 1 study testing Cisplatin, Docetaxel and Laboratory Biomarker Analysis in people with Stage IB Non-Small Cell Lung Carcinoma AJCC v7 and Stage II Non-Small Cell Lung Cancer AJCC v7, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of nintedanib when given together with cisplatin and docetaxel and to see how well they work in treating patients with previously untreated stage IB-IIIA non-small cell lung cancer who are undergoing surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IB Non-Small Cell Lung Carcinoma AJCC v7, Stage II Non-Small Cell Lung Cancer AJCC v7, Stage IIA Non-Small Cell Lung Carcinoma AJCC v7
- What is being tested?
- Cisplatin, Docetaxel and Laboratory Biomarker Analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2015to 6 May 2024
- Phase
- Phase 1
- 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
- Histologically or cytologically confirmed non-small cell lung cancer; patients with a suspected lung cancer are eligible, but pathology must be confirmed prior to initiating treatment on study; neuroendocrine carcinomas are not eligible; carcinomas with neuroendocrine differentiation are eligible
- Stage IB (with a primary tumor >= 4 cm), IIA, IIB, or IIIA (according to American Joint Committee on Cancer [AJCC] 7th edition); patients with stage IIIA must not have more than one mediastinal lymph node station involved by tumor
- All patients must have lymph node evaluation of contralateral stations 2 and/or 4 to exclude N3 disease
- The patient must be a suitable candidate for surgery, in the opinion of the treating physician
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
- Signed and dated written informed consent prior to admission to the study in accordance with International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)-Good Clinical Practice (GCP) guidelines and to the local legislation
Who cannot join
- Prior systemic therapy or radiation therapy for treatment of the current lung cancer
- Known hypersensitivity to the trial drugs or to their excipients
- Centrally located tumors with radiographic evidence (CT or magnetic resonance imaging [MRI]) of local invasion of major blood vessels
- Major injuries within the past 10 days prior to start of study treatment with incomplete wound healing
- History of clinically significant hemorrhagic or thromboembolic event in the past 6 months
- Known inherited predisposition to bleeding or thrombosis
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- Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within the past 12 months prior to start of study treatment, congestive heart failure > New York Heart Association [NYHA] II, serious cardiac arrhythmia, pericardial effusion)
- Creatinine > 1.5 x the upper limit of normal; patients with creatinine > 1.5 x the upper limit of normal who have creatinine clearance >= 60 cc/min (calculated using the Cockcroft and Gault equation) are eligible
- Total bilirubin > institutional upper limit of normal or
- Aspartate aminotransferase (AST) > 1.5 x institutional upper limit of normal
- International normalized ratio (INR) > 2
- Prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional upper limit of normal (ULN)
- Absolute neutrophil count (ANC) < 1500/ml, and/or
- Platelets < 100000/ml
- Prior malignancy requiring systemic therapy or radiation therapy within 1 year of randomization
- Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy
- Known disease or history of active or chronic hepatitis C and/or B infection
- Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
- Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study
- Patients who are sexually active, with preserved reproductive capacity, and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least three months after end of active therapy
- Pregnancy or breast feeding
- Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Induction Cisplatin, Docetaxel, and Nintedanib for Stage IB-IIIA Non-Small Cell Lung Cancers Amenable for Surgical Resection
This phase I trial studies the side effects and best dose of nintedanib when given together with cisplatin and docetaxel and to see how well they work in treating patients with previously untreated stage IB-IIIA non-small cell lung cancer who are undergoing surgery. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cisplatin, docetaxel, and nintedanib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine safety of nintedanib incorporated to chemotherapy in the induction setting.
II. To determine the major pathologic response rate in patients treated with induction nintedanib and chemotherapy.
SECONDARY OBJECTIVES:
- Response rates to induction treatment (by Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1).
II. Response rates to priming therapy with nintedanib single agent (by computed tomography [CT] assessment using RECIST version 1.1).
III. Recurrence-free survival. IV. Overall survival. V. Correlations between major pathologic response with recurrence-free and overall survival.
VI. Toxicity (assessed by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4).
VII. Peri-operative morbidity and mortality. VIII. Complete resection (R0) rate. IX. Correlations of response assessed by imaging studies with outcomes (both pathologic response to treatment and long-term recurrence-free survival).
- Correlations of blood- and tissue-based biomarkers with efficacy and toxicity.
OUTLINE: This is a dose-escalation study of nintedanib.
RUN-IN PHASE: Patients receive induction therapy comprising cisplatin intravenously (IV) over 2 hours on day 1, docetaxel IV over 1 hour on day 1, and nintedanib orally (PO) twice daily (BID) from day 2 of course 1 to day 7 of course 3. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
EXPANSION PHASE: Patients receive single-agent nintedanib PO BID on days 1-28. Patients then receive 3 courses of induction chemotherapy and undergo surgery as above. Treatment continues even if patients experience disease progression, unless treatment is judged to be not in the best interest of the patient by the treating physician.
After completion of study treatment, patients are followed up within 8 weeks and then periodically thereafter.
- Conditions
- Stage IB Non-Small Cell Lung Carcinoma AJCC v7, Stage II Non-Small Cell Lung Cancer AJCC v7, Stage IIA Non-Small Cell Lung Carcinoma AJCC v7, Stage IIB Non-Small Cell Lung Carcinoma AJCC v7, Stage IIIA Non-Small Cell Lung Cancer AJCC v7
- 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.
CisplatinDrug
Also called Abiplatin, Blastolem, Briplatin, CDDP
Given IV
DocetaxelDrug
Also called Docecad, RP56976, Taxotere, Taxotere Injection Concentrate
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
NintedanibDrug
Also called BIBF 1120, BIBF-1120, Intedanib, Multitargeted Tyrosine Kinase Inhibitor BIBF 1120
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (cisplatin, docetaxel, nintedanib) | Experimental | RUN-IN PHASE: Patients receive induction therapy comprising cisplatin IV over 2 hours on day 1, docetaxel IV over 1 hour on day 1, and nintedanib PO BID from day 2 of course 1 to day 7 of course 3. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
EXPANSION PHASE: Patients receive single-agent nintedanib PO BID on days 1-28. Patients then receive 3 courses of induction chemotherapy and undergo surgery as above. Treatment continues even if patients experience disease progression, unless treatment is judged to be not in the best interest of the patient by the treating physician. Receives: Drug: Cisplatin; Drug: Docetaxel; Other: Laboratory Biomarker Analysis; Drug: Nintedanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of nintedanib
Will be determined according to incidence of dose-limiting toxicity as graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Measured: 21 days
Major pathologic response rate, defined as less than or equal to 10% viable tumor cells in the resected specimen using the methods described by Pataer
Multivariate analysis will be used to explore the role of biomarkers in predicting pathologic response to treatment, in an exploratory way.
Measured: Up to 5 years
Secondary outcomes (2)
Change in tumor size (Expansion phase)
Will be assessed by computed tomography (CT) after single-agent nintedanib.
Measured: Baseline to 4 weeks
Response rate after single-agent nintedanib (Expansion phase)
Will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study start3 Apr 2015
- Primary completion6 May 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IB Non-Small Cell Lung Carcinoma AJCC v7Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tina Cascone, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225405
- Sponsor's protocol ID
- 2013-0844
- Other IDs
- NCI-2014-02091, 2013-0844
- Status last verified
- May 2024
- First submitted
- 22 Aug 2014
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Induction Cisplatin, Docetaxel, and Nintedanib for Stage IB-IIIA Non-Small Cell Lung Cancers Amenable for Surgical Resection
- ClinicalTrials.gov ID
- NCT02225405
- Acronym / sponsor ID
- 2013-0844
- Conditions
- Stage IB Non-Small Cell Lung Carcinoma AJCC v7, Stage II Non-Small Cell Lung Cancer AJCC v7, Stage IIA Non-Small Cell Lung Carcinoma AJCC v7, Stage IIB Non-Small Cell Lung Carcinoma AJCC v7, Stage IIIA Non-Small Cell Lung Cancer AJCC v7
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Apr 2015 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 26 Aug 2014 (estimated)
- 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.
This phase I trial studies the side effects and best dose of nintedanib when given together with cisplatin and docetaxel and to see how well they work in treating patients with previously untreated stage IB-IIIA non-small cell lung cancer who are undergoing surgery. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cisplatin, docetaxel, and nintedanib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Detailed description
PRIMARY OBJECTIVES:
- To determine safety of nintedanib incorporated to chemotherapy in the induction setting.
II. To determine the major pathologic response rate in patients treated with induction nintedanib and chemotherapy.
SECONDARY OBJECTIVES:
- Response rates to induction treatment (by Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1).
II. Response rates to priming therapy with nintedanib single agent (by computed tomography [CT] assessment using RECIST version 1.1).
III. Recurrence-free survival. IV. Overall survival. V. Correlations between major pathologic response with recurrence-free and overall survival.
VI. Toxicity (assessed by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4).
VII. Peri-operative morbidity and mortality. VIII. Complete resection (R0) rate. IX. Correlations of response assessed by imaging studies with outcomes (both pathologic response to treatment and long-term recurrence-free survival).
- Correlations of blood- and tissue-based biomarkers with efficacy and toxicity.
OUTLINE: This is a dose-escalation study of nintedanib.
RUN-IN PHASE: Patients receive induction therapy comprising cisplatin intravenously (IV) over 2 hours on day 1, docetaxel IV over 1 hour on day 1, and nintedanib orally (PO) twice daily (BID) from day 2 of course 1 to day 7 of course 3. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
EXPANSION PHASE: Patients receive single-agent nintedanib PO BID on days 1-28. Patients then receive 3 courses of induction chemotherapy and undergo surgery as above. Treatment continues even if patients experience disease progression, unless treatment is judged to be not in the best interest of the patient by the treating physician.
After completion of study treatment, patients are followed up within 8 weeks and then periodically thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (cisplatin, docetaxel, nintedanib) | Experimental | Drug: Cisplatin, Drug: Docetaxel, Other: Laboratory Biomarker Analysis, Drug: NintedanibRUN-IN PHASE: Patients receive induction therapy comprising cisplatin IV over 2 hours on day 1, docetaxel IV over 1 hour on day 1, and nintedanib PO BID from day 2 of course 1 to day 7 of course 3. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. EXPANSION PHASE: Patients receive single-agent nintedanib PO BID on days 1-28. Patients then receive 3 courses of induction chemotherapy and undergo surgery as above. Treatment continues even if patients experience disease progression, unless treatment is judged to be not in the best interest of the patient by the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed non-small cell lung cancer; patients with a suspected lung cancer are eligible, but pathology must be confirmed prior to initiating treatment on study; neuroendocrine carcinomas are not eligible; carcinomas with neuroendocrine differentiation are eligible
- Stage IB (with a primary tumor >= 4 cm), IIA, IIB, or IIIA (according to American Joint Committee on Cancer [AJCC] 7th edition); patients with stage IIIA must not have more than one mediastinal lymph node station involved by tumor
- All patients must have lymph node evaluation of contralateral stations 2 and/or 4 to exclude N3 disease
- The patient must be a suitable candidate for surgery, in the opinion of the treating physician
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
Key exclusion criteria (22 listed)
- Prior systemic therapy or radiation therapy for treatment of the current lung cancer
- Known hypersensitivity to the trial drugs or to their excipients
- Centrally located tumors with radiographic evidence (CT or magnetic resonance imaging [MRI]) of local invasion of major blood vessels
- Major injuries within the past 10 days prior to start of study treatment with incomplete wound healing
- History of clinically significant hemorrhagic or thromboembolic event in the past 6 months
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: Abiplatin, Blastolem, Briplatin, CDDPGiven IV | Drug | Treatment (cisplatin, docetaxel, nintedanib) |
| DocetaxelAlso: Docecad, RP56976, Taxotere, Taxotere Injection ConcentrateGiven IV | Drug | Treatment (cisplatin, docetaxel, nintedanib) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (cisplatin, docetaxel, nintedanib) |
| NintedanibAlso: BIBF 1120, BIBF-1120, Intedanib, Multitargeted Tyrosine Kinase Inhibitor BIBF 1120Given PO | Drug | Treatment (cisplatin, docetaxel, nintedanib) |
Primary outcome
Maximum tolerated dose (MTD) of nintedanib
Time frame: 21 days
Will be determined according to incidence of dose-limiting toxicity as graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Major pathologic response rate, defined as less than or equal to 10% viable tumor cells in the resected specimen using the methods described by Pataer
Time frame: Up to 5 years
Multivariate analysis will be used to explore the role of biomarkers in predicting pathologic response to treatment, in an exploratory way.
2 secondary outcomes
Change in tumor size (Expansion phase)
Time frame: Baseline to 4 weeks
Response rate after single-agent nintedanib (Expansion phase)
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Tina Cascone principal investigator
M.D. Anderson 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 study testing Cisplatin, Docetaxel and Laboratory Biomarker Analysis in people with Stage IB Non-Small Cell Lung Carcinoma AJCC v7 and Stage II Non-Small Cell Lung Cancer AJCC v7, run by M.D. Anderson Cancer 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 6 inclusion and 22 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 8 May 2024. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum tolerated dose (MTD) of nintedanib (time frame: 21 days). The study lists 2 primary outcomes in all. 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 8 May 2024.