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This study will assess the safety and tolerability, and make a preliminary assessment of activity, of a combination of pertuzumab and erlotinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed on at least one prior chemotherapy regimen. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is less than 100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants will receive IV infusion of pertuzumab at a loading dose of 840 mg on Day 1, followed by a dose of 420 mg every 3 weeks. Erlotinib will be administered daily, at a dose level of 100 mg orally (PO). |
|
| Cohort 2 | Experimental | Participants will receive IV infusion of pertuzumab at a loading dose of 840 mg on Day 1, followed by a dose of 420 mg every 3 weeks. Erlotinib will be administered daily, at a dose level of 150 mg orally (PO). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Erlotinib will be administered as oral tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Dose Limiting Toxicities (DLTs) | A DLT was defined as: Any non-hematological toxicity ≥ Grade 3 according to the Common Terminology Criteria for Adverse Events, version 3.0, except for fever, chills, and flu-like symptoms, which occurred despite adequate participant management. The following Grade 1-3 toxicities were exempt: Grade 1-3 skin and/or epithelial toxicities consistent with erlotinib single agent therapy, unless they did not respond to treatment or dose reduction or interruption (Grade 4 skin and/or epithelial toxicities were considered to be a DLT); Grade 4 neutropenia occurring for > 7 days; febrile neutropenia which occurred despite adequate participant management; Grade 4 thrombocytopenia or any thrombocytopenia requiring platelet transfusion; and any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds. | From baseline to end of the study (up to 42 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Classified as Responders | Responders are participants who achieved either a complete response or a partial response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment. | within 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp | 2020 | Belgium | ||||
Two participants in cohort 2 did not begin experimental study drug treatment in Cycle 1, so were not included in the analysis set.The resulting participant flow includes only participants who received pertuzumab.
Seventeen patients enrolled in 3 centers. Three patients from cohort 1 and 1 patient from cohort 2 completed the 6 cycles of study therapy, as planned.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib 100 mg + Pertuzumab 420 mg | Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously |
| FG001 | Erlotinib 150 mg + Pertuzumab 420 mg | Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All recruited participants who received at least 1 dose of both pertuzumab and erlotinib.
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib 100 mg + Pertuzumab 420 mg | Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Dose Limiting Toxicities (DLTs) | A DLT was defined as: Any non-hematological toxicity ≥ Grade 3 according to the Common Terminology Criteria for Adverse Events, version 3.0, except for fever, chills, and flu-like symptoms, which occurred despite adequate participant management. The following Grade 1-3 toxicities were exempt: Grade 1-3 skin and/or epithelial toxicities consistent with erlotinib single agent therapy, unless they did not respond to treatment or dose reduction or interruption (Grade 4 skin and/or epithelial toxicities were considered to be a DLT); Grade 4 neutropenia occurring for > 7 days; febrile neutropenia which occurred despite adequate participant management; Grade 4 thrombocytopenia or any thrombocytopenia requiring platelet transfusion; and any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds. | Posted | Number | Percentage of participants | From baseline to end of the study (up to 42 weeks) |
|
Timeframe was up to 42 weeks
All participants who received at least 1 dose of both pertuzumab and erlotinib and had at least 1 post-baseline safety follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Erlotinib 100 mg + pertuzumab 420 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
Per Version A the protocol was halted for 2 DLTs (grade 3 manageable rash common for erlotinib) in the first 6 patients. Ethics committee approved redefining DLT and starting anew with Version B. No further DLTs were observed throughout the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| C485206 | pertuzumab |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Pertuzumab | Drug | Pertuzumab will be administered as intravenous (IV) infusion. |
|
|
| Percentage of Participants With a Complete Response or Partial Response at the End of Cycles 1, 2, 3, 4, and 6 | Complete and partial responses were determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A complete response was defined as the disappearance of all target and non-target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. | From baseline to the end of the study (up to 42 weeks) |
| Peak Plasma Concentration (Cmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC | Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, typically measured in nanograms/milliliter (ng/mL), reported as mg/L. | on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion |
| Time of Cmax (Tmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC | The time at which maximum concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, is reached (Tmax). | on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion |
| Terminal Phase Plasma Half-life (t ½) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC | Terminal phase plasma half-life (t ½) is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, rather than the time required to eliminate half the administered dose. | on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion |
| Area Under the Plasma Concentration Versus Time Curve (AUC) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With Non-small Cell Lung Cancer (NSCLC) | Bioavailability [AUC(0-t)] is a measure of how much of the drug reaches the person's bloodstream from time 0 (pre-dose) to a given time point (t) for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The Area Under the Curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour * nanograms (ng) per milliliter (mL), which equates to mg.day/L. Bioavailability Extrapolated to Infinity [AUC (0-inf)] is a calculated measure of how much of the drug will ever reach the person's bloodstream for the body to use. AUC (0-inf) stands for the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (forever). It is obtained from calculating AUC (0-t) plus AUC (t-inf). | on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion |
| Clearance (CL) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC | A fundamental concept in pharmacokinetics is drug clearance (CL), that is, elimination of drugs from the body. The clearance is simply the ratio of the dose to the area under the curve (AUC), so that the higher the AUC for a given dose, the lower the clearance. If a drug is administered by continuous infusion and a steady state is achieved, the clearance can be estimated from a single measurement of the plasma drug concentration. | on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion |
| Volume of Distribution at Steady-state (Vss) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC | Steady-state volume of distribution of a drug is an estimate of drug distribution independent of elimination processes. It is most useful for predicting the plasma concentrations following multiple dosing to a steady-state or pseudo-equilibrium. Vss is proportional to the amount of drug in the body versus the plasma concentration of the drug at steady state (pseudo-equilibrium). It is a calculated measure. | on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion |
| Barcelona |
| 08035 |
| Spain |
| Manchester | M20 4BX | United Kingdom |
| Refused treatment |
|
| Adverse Event |
|
| Erlotinib 150 mg + Pertuzumab 420 mg |
Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously |
| OG001 | Erlotinib 150 mg + Pertuzumab 420 mg | Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously. |
|
|
| Secondary | Percentage of Participants Classified as Responders | Responders are participants who achieved either a complete response or a partial response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment. | Full analysis set | Posted | Number | percentage of participants | within 18 weeks |
|
|
|
| Secondary | Percentage of Participants With a Complete Response or Partial Response at the End of Cycles 1, 2, 3, 4, and 6 | Complete and partial responses were determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A complete response was defined as the disappearance of all target and non-target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. | Posted | Number | Percentage of participants | From baseline to the end of the study (up to 42 weeks) |
|
|
|
| Secondary | Peak Plasma Concentration (Cmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC | Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, typically measured in nanograms/milliliter (ng/mL), reported as mg/L. | Pharmacokinetic analysis subset, defined as all participants from either cohort with adequate data for performing PK analysis | Posted | Mean | Standard Deviation | mg/L | on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion |
|
|
|
| Secondary | Time of Cmax (Tmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC | The time at which maximum concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, is reached (Tmax). | PK analysis subset | Posted | Mean | Standard Deviation | days | on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion |
|
|
|
| Secondary | Terminal Phase Plasma Half-life (t ½) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC | Terminal phase plasma half-life (t ½) is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, rather than the time required to eliminate half the administered dose. | PK analysis subset with adequate data for this analysis | Posted | Mean | Standard Deviation | days | on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion |
|
|
|
| Secondary | Area Under the Plasma Concentration Versus Time Curve (AUC) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With Non-small Cell Lung Cancer (NSCLC) | Bioavailability [AUC(0-t)] is a measure of how much of the drug reaches the person's bloodstream from time 0 (pre-dose) to a given time point (t) for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The Area Under the Curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour * nanograms (ng) per milliliter (mL), which equates to mg.day/L. Bioavailability Extrapolated to Infinity [AUC (0-inf)] is a calculated measure of how much of the drug will ever reach the person's bloodstream for the body to use. AUC (0-inf) stands for the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (forever). It is obtained from calculating AUC (0-t) plus AUC (t-inf). | Pharmacokinetic analysis subset with appropriate data available | Posted | Mean | Standard Deviation | mg*day/L | on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion |
|
|
|
| Secondary | Clearance (CL) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC | A fundamental concept in pharmacokinetics is drug clearance (CL), that is, elimination of drugs from the body. The clearance is simply the ratio of the dose to the area under the curve (AUC), so that the higher the AUC for a given dose, the lower the clearance. If a drug is administered by continuous infusion and a steady state is achieved, the clearance can be estimated from a single measurement of the plasma drug concentration. | PK subset | Posted | Mean | Standard Deviation | L/day | on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion |
|
|
|
| Secondary | Volume of Distribution at Steady-state (Vss) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC | Steady-state volume of distribution of a drug is an estimate of drug distribution independent of elimination processes. It is most useful for predicting the plasma concentrations following multiple dosing to a steady-state or pseudo-equilibrium. Vss is proportional to the amount of drug in the body versus the plasma concentration of the drug at steady state (pseudo-equilibrium). It is a calculated measure. | PK analysis subset | Posted | Mean | Standard Deviation | Liters | on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion |
|
|
|
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | Cohort 2 | Erlotinib 150 mg + pertuzumab 420 mg | 4 | 9 | 9 | 9 |
| Diarrhea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Lung Cancer Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment | Sudden death due to progressive disease |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Anal Fissure | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nail Bed Inflammation | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Mucosal Inflammation | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Axillary Pain | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Neurotoxicity | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Fungal Infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Lung Infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Nail Infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Oral Fungal Infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Tinea Pedis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
|
| Xerophthalmia | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study.
The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Cycle 3 |
|
| Cycle 4 |
|
| Cycle 6 |
|