18 and older, 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.
Recommended Phase 2 Dose (RP2D) - Phase 1Primary· Baseline up to Day 21
The highest dose at which less than (\<) 33 percent (%) of participants experienced dose-limiting toxicities (DLT) was to be designated as the maximum tolerated dose (MTD) as well as the RP2D. DLT was defined as any of the following events: Grade 3/4 (severe or life-threatening/ disabling adverse event \[AE\]) nausea, vomiting, or diarrhea (despite the use of adequate/maximal medical intervention and/or prophylaxis); Grade greater than or equal to (\>=) 3 (severe or life-threatening/disabling AE or death related to AE) non-hematological toxicity; delayed (which delayed scheduled treatment for
PFS4m was defined as percent chance of being event free (event defined as progressive disease \[PD\] or death due to any cause, whichever occurred first) at 4 months. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST), as at least 20 percent (%) increase in the sum of longest dimensions (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
PFS6m was defined as percent chance of being event free (event defined as PD or death due to any cause, whichever occurred first) at 6 months. Progression was defined using RECIST, as at least 20% increase in the sum of longest dimensions (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
OS6m was defined as percent chance of being alive at Month 6.
Group
Value
95% CI
PF-00299804 45 mg - Phase 2
80.7
65.1 – 89.9
Percentage of Participants With Objective Response - Phase 1Secondary· Baseline until disease progression or initiation of new anti-cancer therapy or death, assessed every 2 (odd-numbered) cycles up to 12 months after end of treatment (EOT) (EOT: up to Day 506)
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of the longest dimensions (LDs) of target lesion, taking as reference the baseline sum LD, associated to non-progressive disease response for non-target lesions. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.
Group
Value
95% CI
PF-00299804 30 mg - Phase 1
0.0
0.0 – 45.9
PF-00299804 45 mg - Phase 1
33.3
4.3 – 77.7
Soluble Protein Biomarkers LevelSecondary· Cycle 1 Day 1 (C1D1, Baseline), Day 1 of each odd-numbered cycle up to Cycle 17 for both Phase 1 and Phase 2
Blood specimens were analyzed at a sponsor-designated laboratory for analysis of shed proteins/receptors related to Human Epidermal Growth Factor Receptor (HER) signaling (epidermal growth factor receptor \[EGFR\], HER2). These measurements were determined by enzyme-linked immunosorbent assay (ELISA). The data for all Phase 1 participants was combined for this outcome.
EGFR: C1D1
Group
Value
95% CI
PF-00299804 - Phase 1 All Participants
58.57
± 7.498
PF-00299804 45 mg - Phase 2
57.41
± 13.146
EGFR: C3D1
Group
Value
95% CI
PF-00299804 - Phase 1 All Participants
47.46
± 7.845
PF-00299804 45 mg - Phase 2
50.81
± 11.465
EGFR: C5D1
Group
Value
95% CI
PF-00299804 - Phase 1 All Participants
46.76
± 5.395
PF-00299804 45 mg - Phase 2
58.87
± 13.627
EGFR: C7D1
Group
Value
95% CI
PF-00299804 - Phase 1 All Participants
48.58
± NA
PF-00299804 45 mg - Phase 2
55.83
± 19.34
EGFR: C9D1
Group
Value
95% CI
PF-00299804 - Phase 1 All Participants
42.83
± NA
PF-00299804 45 mg - Phase 2
50.32
± 26.214
EGFR: C11D1
Group
Value
95% CI
PF-00299804 - Phase 1 All Participants
40.98
± NA
PF-00299804 45 mg - Phase 2
63.69
± 28.908
EGFR: C13D1
Group
Value
95% CI
PF-00299804 - Phase 1 All Participants
67.34
± NA
PF-00299804 45 mg - Phase 2
73.26
± 29.487
EGFR: C15D1
Group
Value
95% CI
PF-00299804 - Phase 1 All Participants
52
± NA
PF-00299804 45 mg - Phase 2
49.45
± 14.358
Number of Participants With Epidermal Growth Factor Receptor (EGFR), Kirsten Rat Sarcoma (KRAS), and Human Epidermal Growth Factor Receptor-2 (HER2) Mutation StatusSecondary· Screening
Tumor tissue was analyzed at a sponsor-designated laboratory to investigate EGFR, KRAS and HER2 status (wild type or mutated). Participants who did not provide samples for central laboratory analysis confirmation were classified as "unknown". The data for all Phase 1 participants was combined for this outcome.
EGFR Status: Wild Type
Group
Value
95% CI
PF-00299804 - Phase 1 All Participants
3
PF-00299804 45 mg - Phase 2
3
EGFR Status: Mutant
Group
Value
95% CI
PF-00299804 - Phase 1 All Participants
2
PF-00299804 45 mg - Phase 2
12
EGFR Status: Unknown
Group
Value
95% CI
PF-00299804 - Phase 1 All Participants
7
PF-00299804 45 mg - Phase 2
28
KRAS Status: Wild Type
Group
Value
95% CI
PF-00299804 - Phase 1 All Participants
9
PF-00299804 45 mg - Phase 2
29
KRAS Status: Mutant
Group
Value
95% CI
PF-00299804 - Phase 1 All Participants
0
PF-00299804 45 mg - Phase 2
0
KRAS Status: Unknown
Group
Value
95% CI
PF-00299804 - Phase 1 All Participants
3
PF-00299804 45 mg - Phase 2
14
HER2 Status: Wild Type
Group
Value
95% CI
PF-00299804 - Phase 1 All Participants
0
PF-00299804 45 mg - Phase 2
9
HER2 Status: Mutant
Group
Value
95% CI
PF-00299804 - Phase 1 All Participants
0
PF-00299804 45 mg - Phase 2
1
Maximum Observed Plasma Concentration (Cmax) of PF-00299804 30 mg and PF-00299804 45 mgSecondary· 0 (pre-dose), 2, 4, 6, 8, 24, 72, 144, 216 hours post-dose on C0D-9 for Phase 1, 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on C1D14 for Phase 1 and 2
Data in "PF-00299804 45 mg" treatment arm at Cycle 0 Day -9 (C0D-9) represents participants from Phase 1 only and at C1D14 represents participants from both Phase 1 and Phase 2.
C0D-9
Group
Value
95% CI
PF-00299804 30 mg - Phase 1
13.34
± 4.8205
PF-00299804 45 mg
21.30
± 12.356
C1D14
Group
Value
95% CI
PF-00299804 30 mg - Phase 1
56.96
± 20.572
PF-00299804 45 mg
82.71
± 38.788
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-00299804 30 mg and PF-00299804 45 mgSecondary· 0 (pre-dose), 2, 4, 6, 8, 24, 72, 144, 216 hours post-dose on Cycle 0 Day -9 (C0D-9) for Phase 1, 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on C1D14 for Phase 1 and 2
Data in "PF-00299804 45 mg" treatment arm at C0D-9 represents participants from Phase 1 only and at C1D14 represents participants from both Phase 1 and Phase 2.
C0D-9
Group
Value
95% CI
PF-00299804 30 mg - Phase 1
8.00
4.17 – 24.0
PF-00299804 45 mg
4.96
1.98 – 8.00
C1D14
Group
Value
95% CI
PF-00299804 30 mg - Phase 1
5.03
0.000 – 24.0
PF-00299804 45 mg
6.10
0.000 – 24.0
Plasma Decay Half-Life (t1/2) of PF-00299804 30 mg and PF-00299804 45 mg - Phase 1Secondary· 0 (pre-dose), 2, 4, 6, 8, 24, 72, 144, 216 hours post-dose on Cycle 0 Day -9 (C0D-9)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Group
Value
95% CI
PF-00299804 30 mg - Phase 1
63.60
± 30.271
PF-00299804 45 mg - Phase 1
54.02
± 13.461
Area Under the Curve From Time Zero to 24 Hour Post-Dose (AUC0-24) of PF-00299804 30 mg and PF-00299804 45 mgSecondary· 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on Cycle 0 Day -9 (C0D-9) for Phase 1, 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on C1D14 for Phase 1 and 2
AUC0-24: Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post dose. Data in "PF- 00299804 45 mg" treatment arm at C0D-9 represents participants from Phase 1 only and at C1D14 represents participants from both Phase 1 and Phase 2.
C0D-9
Group
Value
95% CI
PF-00299804 30 mg - Phase 1
221.6
± 87.063
PF-00299804 45 mg
354.8
± 153.31
C1D14
Group
Value
95% CI
PF-00299804 30 mg - Phase 1
1075
± 515.66
PF-00299804 45 mg
1621
± 664.87
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-00299804 30 mg and PF-00299804 45 mg- Phase 1Secondary· 0 (pre-dose), 2, 4, 6, 8, 24, 72, 144, 216 hours post-dose on C0D-9
AUClast: Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration.
Group
Value
95% CI
PF-00299804 30 mg - Phase 1
893.4
± 516.50
PF-00299804 45 mg - Phase 1
1248
± 522.11
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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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: 19 October 2020
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/NCT00553254.