Adults 18 to 99, any sex, with Carcinoma, Non Small Cell Lung. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Best Overall Response (BOR) in Participants With Adenocarcinoma HistologyPrimary· Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
BOR:best response recorded from treatment start until disease progression as per Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response: disappearance of all lesions. Partial Response (PR):greater than or equal to (\>=)30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD. Progressive disease (PD):\>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of \>=1 new lesion. Stable disease:neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment sta
Complete response
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
0
Partial response
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
2
Stable or No response
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
28
Objective progression
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
12
Indeterminate
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
0
Best Overall Response (BOR) in Participants With Non-Adenocarcinoma HistologySecondary· Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
BOR: best response recorded from treatment start until disease progression as per RECIST. Complete Response: disappearance of all lesions. PR: \>=30% decrease in SLDs of TLs taking as reference baseline SLD. PD: \>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of \>=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.
Complete response
Group
Value
95% CI
PF-00299804 (Non-adenocarcinoma Histology)
0
Partial response
Group
Value
95% CI
PF-00299804 (Non-adenocarcinoma Histology)
1
Stable or no response
Group
Value
95% CI
PF-00299804 (Non-adenocarcinoma Histology)
8
Objective progression
Group
Value
95% CI
PF-00299804 (Non-adenocarcinoma Histology)
7
Indeterminate
Group
Value
95% CI
PF-00299804 (Non-adenocarcinoma Histology)
0
Duration of Response (DR)Secondary· Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
45.2
24.1 – 66.3
PF-00299804 (Non-adenocarcinoma Histology)
12.1
NA – NA
Percent Probability of Progression-free Survival (PFS) at Month 6Secondary· Up to 6 months after the start of study medication
Probability of being event free (event defined as PD or death due to any cause) at 6 months after the first dose of study treatment. PFS was defined as the time from the first dosing date to the date of first documentation of progression or death due to any cause, whichever occurs first. PFS was calculated as (first event date (if not reached, censored at the last known event-free date) minus first dosing date plus 1). Documentation of progression was determined from objective disease assessment based on RECIST v1.0 criteria. PD was defined as at least a 20% increase in the sum of the longest
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
24.3
12.4 – 38.4
PF-00299804 (Non-adenocarcinoma Histology)
8.0
0.5 – 29.8
Percent Probability of Overall Survival at Months 6 and 12Secondary· Months 6, 12
Probability of being alive at 6 and 12 months after the first dose of study medication.
Month 6
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
71.5
56.7 – 82.1
PF-00299804 (Non-adenocarcinoma Histology)
50.0
24.5 – 71.0
Month 12
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
46.3
31.4 – 59.9
PF-00299804 (Non-adenocarcinoma Histology)
21.9
5.6 – 44.9
Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)]Secondary· 0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1
The pharmacokinetic (PK) samples collected between 22-26 hours post dose on Day 1 of Cycle 1 were within the pre-specified time window for the 24-hour post dose sample and were used for calculation of AUC (0-24) on Day 1 of Cycle 1.
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
390.8
± 165.24
PF-00299804 (Non-adenocarcinoma Histology)
397.9
± 258.11
Maximum Observed Plasma Concentration (Cmax)Secondary· 0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
22.61
± 10.315
PF-00299804 (Non-adenocarcinoma Histology)
25.49
± 22.533
Time to Reach Maximum Observed Plasma Concentration (Tmax)Secondary· 0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
6.08
3.00 – 25.1
PF-00299804 (Non-adenocarcinoma Histology)
6.17
5.00 – 25.7
Human Epidermal Growth Factor-2 (HER-2) and Epidermal Growth Factor Receptor (EGFR) Levels in SerumSecondary· Baseline [pre-dose on Cycle 1 Day 1 (C1D1)], then pre-dose on Day 1 of each cycle, end of treatment (Day 936)
Human epidermal growth factor receptor 2 (HER2) is a transmembrane protein that plays a pivotal role in growth factor signal transduction and epidermal growth factor receptor (EGFR) is a cell surface protein that binds to epidermal growth factor. Levels of the HER-2 and EGFR extracellular domains in serum were assessed by enzyme-linked immunosorbent assay (ELISA).
EGFR: C1D1
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
51.25
± 14.86
PF-00299804 (Non-adenocarcinoma Histology)
57.28
± 15.36
EGFR: C2D1
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
45.89
± 12.42
PF-00299804 (Non-adenocarcinoma Histology)
51.05
± 11.35
EGFR: C3D1
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
44.91
± 11.43
PF-00299804 (Non-adenocarcinoma Histology)
46.79
± 7.64
EGFR: C4D1
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
46.26
± 11.7
PF-00299804 (Non-adenocarcinoma Histology)
46.72
± 9.01
EGFR: C5D1
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
45.35
± 11.32
PF-00299804 (Non-adenocarcinoma Histology)
51.2
± 9.76
EGFR: C6D1
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
48.71
± 12.01
PF-00299804 (Non-adenocarcinoma Histology)
66.52
± 20.19
EGFR: C7D1
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
52.85
± 15.6
PF-00299804 (Non-adenocarcinoma Histology)
44.29
± 9.55
EGFR: C8D1
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
50.27
± 17.05
PF-00299804 (Non-adenocarcinoma Histology)
55.93
± NA
Number of Participants With Human Epidermal Growth Factor Family (HER-Family) and Kirsten Rat Sarcoma (KRAS) Gene Mutation Status From Free Tumor Deoxy- Ribonucleic Acid (DNA) in Blood at ScreeningSecondary· Screening
HER-family is a family of transmembrane protein that plays a pivotal role in growth factor signal transduction and Kirsten Rat Sarcoma (KRAS) gene is an oncogene that encodes a small guanosine triphosphatase (GTPase) transductor protein called KRAS. The mutation status of HER and KRAS genes in tumor DNA present in plasma was determined using a polymerase chain reaction (PCR)-based assay. The gene that is most common in a particular natural population is known as the wild type. Any form of the gene other than the wild type is known as a mutant form. Number of participants with HER-Family and KR
KRAS mutation: Wild-type
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
39
PF-00299804 (Non-adenocarcinoma Histology)
15
KRAS mutation: Mutant
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
0
PF-00299804 (Non-adenocarcinoma Histology)
0
KRAS mutation: Unknown
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
11
PF-00299804 (Non-adenocarcinoma Histology)
1
HER-2 mutation: Wild-type
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
29
PF-00299804 (Non-adenocarcinoma Histology)
13
HER-2 mutation: Mutant
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
0
PF-00299804 (Non-adenocarcinoma Histology)
0
HER-2 mutation: Unknown
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
21
PF-00299804 (Non-adenocarcinoma Histology)
3
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) ScoreSecondary· Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
C1D1: GHS
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
65.83
± 24.99
PF-00299804 (Non-adenocarcinoma Histology)
60.56
± 25.87
C1D1: Physical functioning
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
74.70
± 22.17
PF-00299804 (Non-adenocarcinoma Histology)
70.22
± 27.24
C1D1: Role functioning
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
72.67
± 33.46
PF-00299804 (Non-adenocarcinoma Histology)
74.44
± 32.04
C1D1: Emotional Functioning
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
77.72
± 23.87
PF-00299804 (Non-adenocarcinoma Histology)
77.22
± 16.51
C1D1: Cognitive Functioning
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
81.33
± 24.89
PF-00299804 (Non-adenocarcinoma Histology)
76.67
± 28.73
C1D1: Social Functioning
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
76.33
± 30.69
PF-00299804 (Non-adenocarcinoma Histology)
67.78
± 26.33
C1D1: Fatigue
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
36.44
± 25.99
PF-00299804 (Non-adenocarcinoma Histology)
44.44
± 26.89
C1D1: Nausea, vomiting
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
10.33
± 18.10
PF-00299804 (Non-adenocarcinoma Histology)
10.00
± 17.59
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) ScoreSecondary· Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnoea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
C1D1: Dyspnoea
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
25.85
± 22.84
PF-00299804 (Non-adenocarcinoma Histology)
26.98
± 21.67
C1D1: Coughing
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
33.33
± 30.12
PF-00299804 (Non-adenocarcinoma Histology)
33.33
± 25.20
C1D1: Hemoptysis
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
2.00
± 10.45
PF-00299804 (Non-adenocarcinoma Histology)
4.44
± 11.73
C1D1: Sore mouth
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
3.33
± 10.10
PF-00299804 (Non-adenocarcinoma Histology)
6.67
± 18.69
C1D1: Dysphagia
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
2.67
± 9.13
PF-00299804 (Non-adenocarcinoma Histology)
0.00
± 0.00
C1D1: Peripheral neuropathy
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
10.00
± 18.13
PF-00299804 (Non-adenocarcinoma Histology)
13.33
± 24.56
C1D1: Alopecia
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
8.16
± 25.94
PF-00299804 (Non-adenocarcinoma Histology)
22.22
± 37.09
C1D1: Chest pain
Group
Value
95% CI
PF-00299804 (Adenocarcinoma Histology)
14.67
± 27.07
PF-00299804 (Non-adenocarcinoma Histology)
20.00
± 30.34
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
PF-00299804 (Adenocarcinoma Histology)
Serious: 9/50 (18%)
Deaths: —
PF-00299804 (Non-adenocarcinoma Histology)
Serious: 6/16 (38%)
Deaths: —
Serious adverse events (24 terms)
Reaction
System
PF-00299804 (Adenocarcinom…
PF-00299804 (Non-adenocarc…
Disease progression
General disorders
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
Abdominal pain
Gastrointestinal disorders
—
—
Constipation
Gastrointestinal disorders
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
Anaemia
Blood and lymphatic system disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Pancreatitis
Gastrointestinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Asthenia
General disorders
—
—
Cystitis
Infections and infestations
—
—
Pneumonia
Infections and infestations
—
—
Hip fracture
Injury, poisoning and procedural complications
—
—
Spinal compression fracture
Injury, poisoning and procedural complications
—
—
Dehydration
Metabolism and nutrition disorders
—
—
Hypercalcaemia
Metabolism and nutrition disorders
—
—
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Renal failure acute
Renal and urinary disorders
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
Haemoptysis
Respiratory, thoracic and mediastinal disorders
—
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
—
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
—
—
Hypotension
Vascular disorders
—
—
Other adverse events (185 terms — click to expand)
To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804 taken daily, as single agent in patients with advanced NSCLC who failed at least one chemotherapy + erlotinib.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01000025 — PF-00299804 in Stage IIIB or Stage IV Non-Small Cell Lung Cancer Not Responding to Standard Therapy for Advanced or Meta
· Phase 3
· completed
NCT00728390 — A Safety And Efficacy Study Of The Combination Of Oral PF-00299804 And Intravenous CP-751,871 Given Every 3 Weeks
· Phase 1
· completed
NCT00768664 — Open-Label Trial Of Oral PF-00299804 By Continuous Dosing In Patients With Recurrent Or Metastatic Head And Neck Squamou
· Phase 2
· completed
NCT00553254 — Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer
· Phase 2
· completed
NCT00225121 — Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-00299804 In Patients With Advanced Solid Tumo
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 21 May 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00548093.